Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer: medical device reports filed with FDA

16,482 reports carry this product code, 2003–2026; 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.

16,482
reports with this product code: 0.1% of all MAUDE reports; 1,703
reports, 12 months to August 2026: 1,494 in the 12 months before; 24%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code MBH is FDA's classification for "Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer" (orthopedic panel), a class 2 device. 16,482 medical device reports carry this product code, 0.1% of the MAUDE database, from May 2003 to August 2026.

1,703 reports arrived in the 12 months to August 2026, up 14% from 1,494 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 (75.7%), malfunction (24%) and other (0.1%). 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
Triathlon Ps X3 Tibial Insert	660	21	0%	12.9%
Triathlon Cr X3 Tibial Insert	368	13	0%	8.4%
Unknown Knee	367	18	1.5%	0.3%
Triathlon Prim Tib Baseplate - Cemented	190	3	0.5%	13.3%
Triathlon Ps Fem Component Cemented	173	6	0.3%	22.8%
Triathlon Asymmetric X3 Patella	114	6	0%	4.1%
Persona FEMORAL CR IMPACTOR PAD	99	33	0%	99.1%
Nexgen Lps-Flex Prolong Articular Surface	94	0	0%	37.3%
Unknown Stryker knee	91	17	0.5%	2.1%
Femoral Cr Impactor Pad	71	12	0%	99.7%
Tibial Articular Surface Provisional Left Size Ef	67	0	0%	98.8%
Nexgen Cr-Flex Femoral Component	65	0	0%	5.2%
Tibial Articular Surface Provisional Right Size Ef	64	0	0%	99.8%
Unknown Femoral Component	49	90	0.3%	1.6%
R3 Offset Impactor Tip	48	44	0%	86.1%
Unknown Articular Surface	47	78	0%	1.1%
Persona Tibial Articular Surface Provisional	45	0	0%	95.5%
Tibial Articular Surface Provisional Left Size Cd	40	0	0%	99.3%
Tibial Articular Surface Provisional Left Size Gh	39	0	0%	99.2%
Nexgen Lps-Flex Articular Surface	35	0	0%	46.8%
Nexgen Cr-Flex Gsf Femoral Component	33	0	0%	4.2%
Tibial Articular Surface Provisional Right Size Gh	33	0	0%	99.1%
Tibial Articular Surface Provisional Right Size Cd	32	0	0%	99.7%
Femoral Head Impactor	30	9	0%	91.9%
Tibial Articular Surface Provisional	28	0	0%	96.5%
UNK Attune Femoral	25	79	0.2%	2.3%
3d Knee	23	0	0%	1.9%
Journey Dcf Ap Fem Cut Blk 6	22	12	0%	86.2%
Journey Dcf Ap Fem Cut Blk 5	20	13	0%	86.4%
3dknee	19	0	0%	0.7%

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
Stryker Orthopaedics-Mahwah	7,121	43.2%
Zimmer Biomet	2,965	18%
Zimmer Orthopaedic Mfg	1,603	9.7%
Zimmer	818	5%
Smith & Nephew	621	3.8%
Zimmer Manufacturing	292	1.8%
Biomet Orthopedics	252	1.5%
Encore Medical L P	184	1.1%
Stryker Orthopaedics Limerick	105	0.6%
Zimmer Tmt	103	0.6%
Microport Orthopedics	67	0.4%
Mako Surgical	20	0.1%
Depuy-Cork A Division Of Depuy Orthopaedics	16	0.1%
Limacorporate	15	0.1%
Medacta International	14	0.1%

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%11

Injury75.7%12,485

Malfunction24%3,958

Other0.1%20

Not given0%8

Who filed

Manufacturer report99.5%16,405

Voluntary report0.4%60

User facility report0%0

Distributor report0%3

Not given0.1%14

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

Device problems coded

Device problem (FDA code)	Reports	Share
Insufficient device problem information	3,159	19.2%
Fracturea broken bone	1,621	9.8%
Unstable	1,506	9.1%
Breakthe device broke	901	5.5%
Loss of osseointegration	564	3.4%
Loosening of implant not related to bone-ingrowth	404	2.5%
Osseointegration problem	363	2.2%
Difficult to insertthe device was hard to insert	354	2.1%
Detachment of device or device componentpart of the device came off	352	2.1%
Naturally worn	326	2%
Device dislodged or dislocated	260	1.6%
Loose or intermittent connection	255	1.5%
Mechanical problema mechanical problem	252	1.5%
Malposition of device	246	1.5%
Device operates differently than expectedthe device behaved unexpectedly	245	1.5%
Degraded	222	1.3%
Material integrity problema problem with the device material	208	1.3%
Noise, audible	202	1.2%
Migrationthe device moved from where it was placed	198	1.2%
Device slipped	192	1.2%

Questions about prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer reports

What is product code MBH?

FDA's classification code for "Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer", class 2, reviewed by the orthopedic panel. Every device report carries the product code of the device involved.

How many reports carry this code?

16,482 reports through August 2026, 1,703 of them in the latest 12 months.

Which brands appear most often?

Triathlon Ps X3 Tibial Insert (660), Triathlon Cr X3 Tibial Insert (368), Unknown Knee (367), Triathlon Prim Tib Baseplate - Cemented (190) and Triathlon Ps Fem Component Cemented (173). 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.