Device manufacturer, as written on reports

Encore Medical L P: medical device reports filed with FDA

21,566 reports name it as the manufacturer of the device involved, 2002–2026.

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.

21,566
reports naming it as manufacturer: 0.1% of all MAUDE reports; 2,246
reports, 12 months to August 2026: 1,972 in the 12 months before; 3.8%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

21,566 medical device reports received by FDA give Encore Medical L P as the manufacturer of the device involved, 0.1% of the MAUDE database, from May 2002 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

2,246 reports arrived in the 12 months to August 2026, up 14% from 1,972 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 (78.2%), other (17.5%) and malfunction (3.8%). 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
Djo Surgical	Prosthesis, shoulder, semi-constrained, metal/polymer cemented	4,365	2,448	0%
Rsp Shoulder	Prosthesis, shoulder, semi-constrained, metal/polymer cemented	2,000	0	0%
Rsp	Shoulder prosthesis, reverse configuration	1,331	0	0%
Foundation Knee	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	652	0	0%
Empowr 3d Knee	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	597	0	0%
Fmp Hip	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	571	0	0%
Biolox Delta Hip	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented	543	0	0%
Turon Shoulder	Prosthesis, shoulder, semi-constrained, metal/polymer cemented	543	0	0%
Altivate Reverse Shoulder	Prosthesis, shoulder, semi-constrained, metal/polymer cemented	483	0	0%
3dknee	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	456	0	0%
Discovery Elbow	Prosthesis, elbow, constrained, cemented	439	0	0%
3d Knee	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	376	0	0%
Foundation Knee System	Prosthesis, knee, hemi-, tibial, resurfacing (uncemented)	358	0	0%
X-Alt Hip	Hip prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented	328	0	0%
Foundation Hip	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	320	0	0%
Empowr Ps Knee	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	220	0	0%
Taperfill Hip	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	195	0	0%
Delta Hip	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented	149	0	0%
Foundation Shoulder	Prosthesis, shoulder, semi-constrained, metal/polymer cemented	147	0	0%
Altivate Anatomic Shoulder	Prosthesis, shoulder, semi-constrained, metal/polymer cemented	145	0	0%
Empowr Hip	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	144	0	0%
Star	Excimer laser system	52	50	0%
Unknown Knee	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	20	18	1.5%
Unknown Hip	Prosthesis, hip, semi-constrained, metal/polymer, cemented	15	5	1.9%
BIOLOX Delta	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented	4	255	0%
Drill Bit	Bit, drill	3	25	0%
Delta	Monitor, physiological, patient(with arrhythmia detection or alarms)	1	22	7.2%
Femoral Head	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	1	11	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
KWS	Prosthesis, shoulder, semi-constrained, metal/polymer cemented	5,090	23.6%
JWH	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	4,004	18.6%
PHX	Shoulder prosthesis, reverse configuration	3,108	14.4%
LPH	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	2,044	9.5%
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented	1,286	6%
JDC	Prosthesis, elbow, constrained, cemented	760	3.5%
FZX	Guide, surgical, instrument	590	2.7%
OIY	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive	420	1.9%
HSH	Prosthesis, knee, hemi-, tibial, resurfacing (uncemented)	330	1.5%
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented	318	1.5%

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%4

Injury78.2%16,859

Malfunction3.8%815

Other17.5%3,767

Not given0.6%121

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

Questions about Encore Medical L P reports

How many FDA device reports name Encore Medical L P as manufacturer?

21,566 reports through August 2026, 2,246 of them in the latest 12 months.

Which of its brands appear most often?

Djo Surgical (4,365), Rsp Shoulder (2,000), Rsp (1,331), Foundation Knee (652) and Empowr 3d Knee (597).

Which device types does it report on?

prosthesis, shoulder, semi-constrained, metal/polymer cemented (23.6%), prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (18.6%), shoulder prosthesis, reverse configuration (14.4%) and prosthesis, hip, semi-constrained, metal/polymer, porous uncemented (9.5%).

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.