Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented: medical device reports filed with FDA

5,347 reports carry this product code, 1999–2026; 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.

5,347
reports with this product code: 0% of all MAUDE reports; 88
reports, 12 months to August 2026: 120 in the 12 months before; 40.4%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code MRA is FDA's classification for "Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented" (unknown panel), a class 3 device. 5,347 medical device reports carry this product code, 0% of the MAUDE database, from February 1999 to August 2026.

88 reports arrived in the 12 months to August 2026, down 27% from 120 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 (58.8%), malfunction (40.4%) and other (0.5%). 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
Pinn Straight Cup Impactor	1,506	315	0%	99.8%
Trident Alumina Insert	409	0	0%	19%
Lineage R Transcend R Ceramic Femoral Head	126	0	0%	0%
Srom Stm St 36+6l Nk 11x16x150	66	1	0%	2.1%
Srom Stm St 36+8l Nk 18x13x160	52	1	0%	1.7%
Srom Stm Std 36+12l 13x18	51	0	0.3%	2.7%
Delta Cer Head 12/14 36mm +1 5	40	59	0%	1.5%
Delta Cer Head 12/14 36mm +5	33	47	0%	2.4%
Apex Hole Elim Positive Stop	26	20	0.4%	13.9%
Summit Por Taper Sz6 Std Off	21	4	0.4%	3.3%
Summit Por Taper Sz4 Std Off	20	0	0.5%	1.5%
Srom Stm Std 36+12l 15x20	19	0	0%	0.5%
Delta Cer Head 12/14 36mm +8 5	18	22	0%	3%
Delta Cer Head 12/14 32mm +1	14	39	0%	1.1%
Summit Por Taper Sz5 Hi Off	13	0	0.2%	3.5%
Summit Por Taper Sz5 Std Off	13	1	0.2%	3.4%
Summit Por Taper Sz6 Hi Off	12	0	0.6%	3.9%
Srom Stm St 36+8l Nk 20x15x165	11	0	0.9%	1.8%
Summit Por Taper Sz4 Hi Off	11	1	0%	1.7%
Summit Por Taper Sz7 Hi Off	11	0	0.4%	2.9%
Summit Por Taper Sz3 Std Off	10	0	0.4%	4.2%
Mbt Cem Keel Tib Tray Sz4	9	4	0%	0.2%
Delta Cer Head 12/14 28mm +1 5	8	13	0%	4.7%
PROFEMUR Modular Femoral Neck	8	29	0.2%	1.9%
S-Rom Stm Std 36nk 16x11x150	8	0	0.6%	1.2%
Summit Por Taper Sz7 Std Off	8	3	0%	2.1%
Femoral Head Biolox Delta	7	0	0%	0%
Mbt Cem Keel Tib Tray Sz2 5	7	6	0%	0.3%
S-Rom Sleeve Prx Ztt 18d-Lrg	7	0	0%	2.9%
Summit Por Taper Sz8 Hi Off	6	0	0%	3.2%

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
Stryker Orthopaedics Cork	374	7%
Depuy Ireland 9616671	241	4.5%
Wright Medical Technology	235	4.4%
Microport Orthopedics	172	3.2%
Depuy Ireland	111	2.1%
Depuy-Cork A Division Of Depuy Orthopaedics	93	1.7%
Zimmer Manufacturing	87	1.6%
Depuy International	71	1.3%
Stryker Orthopaedics-Mahwah	71	1.3%
Depuy Orthopaedics US 1818910	50	0.9%
Depuy Orthopaedics US	49	0.9%
Depuy Ireland Reg 9616671	45	0.8%
9616671 Depuy Ireland	37	0.7%
Zimmer Switzerland Manufacturing	27	0.5%
Exactech	18	0.3%

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%10

Injury58.8%3,145

Malfunction40.4%2,159

Other0.5%25

Not given0.1%8

Who filed

Manufacturer report99.2%5,305

Voluntary report0.6%34

User facility report0%0

Distributor report0%1

Not given0.1%7

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	1,583	29.6%
Insufficient device problem information	711	13.3%
Fracturea broken bone	688	12.9%
Device dislodged or dislocated	291	5.4%
Explanted	228	4.3%
Noise, audible	221	4.1%
Loss of osseointegration	195	3.6%
Mechanical problema mechanical problem	138	2.6%
Noise	127	2.4%
Implant, removal of	123	2.3%
Replace	101	1.9%
Crackthe device cracked	99	1.9%
Naturally worn	79	1.5%
Malposition of device	75	1.4%
Migration or expulsion of device	68	1.3%
Loose	59	1.1%
Material twisted/bent	56	1%
Corrodedthe device corroded	55	1%
Osseointegration problem	49	0.9%
Material deformation	43	0.8%

Questions about prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented reports

What is product code MRA?

FDA's classification code for "Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

5,347 reports through August 2026, 88 of them in the latest 12 months.

Which brands appear most often?

Pinn Straight Cup Impactor (1,506), Trident Alumina Insert (409), Lineage R Transcend R Ceramic Femoral Head (126), Srom Stm St 36+6l Nk 11x16x150 (66) and Srom Stm St 36+8l Nk 18x13x160 (52). 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.