Device manufacturer, as written on reports

1219655 Depuy-Raynham A Div Of Depuy Orthopaedic: medical device reports filed with FDA

1,592 reports name it as the manufacturer of the device involved, 2012–2017.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

1,592
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 15.2%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

1,592 medical device reports received by FDA give 1219655 Depuy-Raynham A Div Of Depuy Orthopaedic as the manufacturer of the device involved, 0% of the MAUDE database, from April 2012 to September 2017. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (84.8%) and malfunction (15.2%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Hp Mbt Cem Keel Punch Sz 4-7	Orthopedic manual surgical instrument	57	0	0%
Pinn Can Bone Screw 6 5mmx25mm	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	34	32	0%
Pinn Can Bone Screw 6 5mmx20mm	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	24	19	0.3%
Pinn Can Bone Screw 6 5mmx30mm	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	21	22	0.3%
Attune Femoral Impactor	Impactor	17	121	0%
Pinn Can Bone Screw 6 5mmx15mm	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	17	16	0.6%
Attune Impaction Handle	Impactor	12	64	0%
Pinn Can Bone Screw 6 5mmx35mm	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	12	21	0%
Attune Fb Tibial Impactor	Impactor	11	114	0%
Pfc Sigma/Ov/Dome Pat 3peg 38	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	11	3	0.4%
Sig Mod Tib Tray Cem Cocr 2 5	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	11	2	0.2%
Lcs Comp Rp Insert Std 10mm	Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing	9	7	0%
Universal Stem 75x16mm Fluted	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	7	3	0%
Attune Rp Tibial Impactor	Impactor	6	32	0%
Mbt Revision Cem Tib Tray Sz 4	Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing	6	0	0%
Pfc Sigma/Ov/Dome Pat 3peg 41	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	6	4	0%
Pinn Can Bone Screw 6 5mmx40mm	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	6	3	0%
Sigma Fem Adapter 5 Degree	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	6	9	0%
Attune Mod Post Saw Cap Sz 6-8	Orthopedic manual surgical instrument	5	41	0%
Lcs Comp Rp Insert Std+ 10mm	Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing	5	3	0%
Sp2 Tibial Radel Impactor	Impactor	5	2	0%
Altrx +4 10d 36idx52od	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	4	17	0.2%
Altrx Neut 36idx56od	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	4	13	0%
Attune Fb Cr Artic Surf Sz6	Template	4	31	0%
Attune Mes Sizing/Rot Gde	Template	4	36	0%
Attune Rp Ps Artic Surf Sz6	Template	4	15	0%
Attune Spacer Block	Template	4	80	0%
Pfc Calibrated Pat Cut Gde	Template	4	1	0%
Sig Fem Adap +2/-2 Offset Bolt	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	4	7	0%
Sig Mod Tib Tray Cem Cocr 3	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	3	3	0%

Brands with a page on this site, ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Device types

Product code	Device type	Reports	Share
JWH	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	706	44.3%
NJL	Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing	270	17%
LXH	Orthopedic manual surgical instrument	191	12%
LPH	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	138	8.7%
NDJ	Screw, fixation, bone, non-spinal, metallic	64	4%
HRY	Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer	55	3.5%
KWA	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	48	3%
KRO	Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer	33	2.1%
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented	24	1.5%
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented	9	0.6%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death0%0

Injury84.8%1,350

Malfunction15.2%242

Other0%0

Not given0%0

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about 1219655 Depuy-Raynham A Div Of Depuy Orthopaedic reports

How many FDA device reports name 1219655 Depuy-Raynham A Div Of Depuy Orthopaedic as manufacturer?

1,592 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Hp Mbt Cem Keel Punch Sz 4-7 (57), Pinn Can Bone Screw 6 5mmx25mm (34), Pinn Can Bone Screw 6 5mmx20mm (24), Pinn Can Bone Screw 6 5mmx30mm (21) and Attune Femoral Impactor (17).

Which device types does it report on?

prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (44.3%), prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing (17%), orthopedic manual surgical instrument (12%) and prosthesis, hip, semi-constrained, metal/polymer, porous uncemented (8.7%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.