Prosthesis, shoulder, non-constrained, metal/polymer cemented: medical device reports filed with FDA

5,693 reports carry this product code, 1996–2026; 16 brands with a page.

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.

5,693
reports with this product code: 0% of all MAUDE reports; 641
reports, 12 months to August 2026: 781 in the 12 months before; 12.5%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code KWT is FDA's classification for "Prosthesis, shoulder, non-constrained, metal/polymer cemented" (orthopedic panel), a class 2 device. 5,693 medical device reports carry this product code, 0% of the MAUDE database, from December 1996 to August 2026.

641 reports arrived in the 12 months to August 2026, down 18% from 781 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 (85.7%), malfunction (12.5%) and other (1.4%). 16 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Equinoxe	993	108	0.1%	9.8%
Equinoxe Reverse Shoulder Components	255	200	0%	0.2%
Specific Device Not Reported	168	20	0.2%	0.1%
Equinoxe Reverse Humeral Adapter Tray	132	0	0%	36.6%
Equinoxe Reverse Humeral Liner	129	0	0%	38.2%
SMR Shoulder	60	161	0%	9.7%
Modular Center Post Reamer	7	21	0%	96.5%
Screw	2	0	0%	14.8%
Unknown Extremity	2	0	1.9%	1.9%
Comp Rvrs 25mm Bsplt Ha+adptr	1	17	0%	2.9%
Exactech	1	0	0%	53.6%
Unk head	1	146	0.5%	0.2%
Unk Reamer	1	71	0%	96.3%
Unknown Knee Components	1	42	0.3%	6.1%
Unknown Shoulder Humeral Stems	1	8	1.7%	5%
Unknown Shoulder Implant	1	8	0.8%	2.4%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Exactech	3,742	65.7%
Limacorporate	259	4.5%
Zimmer Tmt	37	0.6%
Biomet	25	0.4%
Ascension Orthopedics	21	0.4%
Tornier	21	0.4%
Synthes Selzach	10	0.2%
Depuy France Sas 3003895575	7	0.1%
Depuy International 8010379	7	0.1%
Fx Solutions	7	0.1%
Onkos Surgical	5	0.1%
Biomet Orthopedics	1	0%
C R Bard Basd	1	0%
Depuy France	1	0%
Depuy International	1	0%

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 and report source

Event type

Death0.2%11

Injury85.7%4,879

Malfunction12.5%712

Other1.4%80

Not given0.2%11

Who filed

Manufacturer report99.2%5,650

Voluntary report0.5%28

User facility report0%0

Distributor report0%1

Not given0.2%14

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Device dislodged or dislocated	934	16.4%
Insufficient device problem information	602	10.6%
Detachment of device or device componentpart of the device came off	484	8.5%
Fracturea broken bone	445	7.8%
Naturally worn	408	7.2%
Loosening of implant not related to bone-ingrowth	342	6%
Unstable	289	5.1%
Loose or intermittent connection	228	4%
Breakthe device broke	215	3.8%
Implant, removal of	120	2.1%
Device slipped	90	1.6%
Explanted	89	1.6%
Migrationthe device moved from where it was placed	82	1.4%
Migration or expulsion of device	75	1.3%
Loss of or failure to bond	64	1.1%
Device operates differently than expectedthe device behaved unexpectedly	59	1%
Loose	58	1%
Detachment of device component	56	1%
Mechanical problema mechanical problem	45	0.8%
Patient device interaction problem	42	0.7%

Questions about prosthesis, shoulder, non-constrained, metal/polymer cemented reports

What is product code KWT?

FDA's classification code for "Prosthesis, shoulder, non-constrained, metal/polymer cemented", class 2, reviewed by the orthopedic panel. Every device report carries the product code of the device involved.

How many reports carry this code?

5,693 reports through August 2026, 641 of them in the latest 12 months.

Which brands appear most often?

Equinoxe (993), Equinoxe Reverse Shoulder Components (255), Specific Device Not Reported (168), Equinoxe Reverse Humeral Adapter Tray (132) and Equinoxe Reverse Humeral Liner (129). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. 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 differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.