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

23,454 reports carry this product code, 1996–2026; 30 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.

23,454
reports with this product code: 0.1% of all MAUDE reports; 2,500
reports, 12 months to August 2026: 2,215 in the 12 months before; 10.9%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code KWS is FDA's classification for "Prosthesis, shoulder, semi-constrained, metal/polymer cemented" (orthopedic panel), a class 2 device. 23,454 medical device reports carry this product code, 0.1% of the MAUDE database, from December 1996 to August 2026.

2,500 reports arrived in the 12 months to August 2026, up 13% from 2,215 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 (83.5%), malfunction (10.9%) and other (5.2%). 30 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
Rsp Shoulder	1,690	0	0%	1.2%
Djo Surgical	1,115	2,448	0%	1%
Turon Shoulder	525	0	0%	0.9%
Altivate Reverse Shoulder	455	0	0%	0.8%
Unknown Shoulder Glenosphere	211	24	0.3%	1.5%
Modular Center Post Reamer	165	21	0%	96.5%
Compr Metal Impactor	162	37	0%	99.4%
Comp Rvrs 25mm Bsplt Ha+adptr	157	17	0%	2.9%
Altivate Anatomic Shoulder	143	0	0%	3.3%
Foundation Shoulder	129	0	0%	1.3%
Unknown Shoulder Humeral Stems	102	8	1.7%	5%
Unknown Shoulder Implant	101	8	0.8%	2.4%
Dxtend Glenosphere Std D38mm	100	5	0%	14.2%
Unknown Shoulder Metaglene	97	16	0.3%	8.5%
Dxtend Metaglene	96	14	0%	11.8%
Unknown Shoulder Humeral Cup	94	12	0.4%	1.2%
Dxtend Stand Pe Cup D38 +3mm	93	8	0%	6.2%
Unknown Glenoid	91	26	0%	0.9%
Comp Rvrs Shldr Glnsp Std 36mm	88	12	1.2%	1.8%
Unknown Peripheral Screw	78	24	0%	0.6%
Dxtend Glenosphere Ecc D38mm	76	2	0%	9.9%
Unknown Shoulder Locking Screw	69	25	0.4%	4.1%
Dxtend Glenosphere Std D42mm	66	3	0%	18.5%
SMR Shoulder	58	161	0%	9.7%
Unknown Extremity	58	0	1.9%	1.9%
Unknown Humeral Stem	58	15	1.2%	0.6%
Dxtend Stand Pe Cup D38 +6mm	56	2	0%	6.1%
Equinoxe Reverse Shoulder Components	51	200	0%	0.2%
Specific Device Not Reported	49	20	0.2%	0.1%
Dxtend Stand Pe Cup D42 +3mm	45	7	0%	6.7%

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
Encore Medical L P	5,090	21.7%
Tornier S	3,356	14.3%
Zimmer Biomet	3,225	13.8%
Exactech	1,407	6%
Tornier	1,217	5.2%
Biomet Orthopedics	989	4.2%
Stryker	763	3.3%
Arthrex	659	2.8%
Depuy France	571	2.4%
Limacorporate	375	1.6%
Depuy France Sas - 3003895575	345	1.5%
Depuy France Sas 3003895575	311	1.3%
Ascension Orthopedics	159	0.7%
Depuy Orthopaedics	142	0.6%
Stanmore Implants Worldwide	91	0.4%

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

Death0.1%33

Injury83.5%19,585

Malfunction10.9%2,553

Other5.2%1,214

Not given0.3%69

Who filed

Manufacturer report99.4%23,324

Voluntary report0.4%89

User facility report0%0

Distributor report0%3

Not given0.2%38

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

Device problems coded

Device problem (FDA code)	Reports	Share
Device dislodged or dislocated	3,642	15.5%
Insufficient device problem information	2,425	10.3%
Fracturea broken bone	1,834	7.8%
Unstable	1,197	5.1%
Breakthe device broke	907	3.9%
Loosening of implant not related to bone-ingrowth	861	3.7%
Naturally worn	629	2.7%
Loose or intermittent connection	578	2.5%
Detachment of device or device componentpart of the device came off	480	2%
Loss of osseointegration	456	1.9%
Implant, removal of	410	1.7%
Device slipped	391	1.7%
Device operates differently than expectedthe device behaved unexpectedly	350	1.5%
Patient device interaction problem	328	1.4%
Osseointegration problem	302	1.3%
Migrationthe device moved from where it was placed	289	1.2%
Explanted	285	1.2%
Loss of or failure to bond	261	1.1%
Migration or expulsion of device	261	1.1%
Difficult to insertthe device was hard to insert	221	0.9%

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

What is product code KWS?

FDA's classification code for "Prosthesis, shoulder, semi-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?

23,454 reports through August 2026, 2,500 of them in the latest 12 months.

Which brands appear most often?

Rsp Shoulder (1,690), Djo Surgical (1,115), Turon Shoulder (525), Altivate Reverse Shoulder (455) and Unknown Shoulder Glenosphere (211). 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.