Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing: medical device reports filed with FDA

26,046 reports carry this product code, 2004–2026; 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.

26,046
reports with this product code: 0.1% of all MAUDE reports; 929
reports, 12 months to August 2026: 1,124 in the 12 months before; 3.2%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code NJL is FDA's classification for "Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing" (unknown panel), a class 3 device. 26,046 medical device reports carry this product code, 0.1% of the MAUDE database, from May 2004 to August 2026.

929 reports arrived in the 12 months to August 2026, down 17% from 1,124 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 (96.8%) and malfunction (3.2%). 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
Mbt Cem Keel Tib Tray Sz3	1,028	9	0%	0.6%
Mbt Cem Keel Tib Tray Sz4	616	4	0%	0.2%
Mbt Cem Keel Tib Tray Sz2 5	615	6	0%	0.3%
Attune Rp Tib Base Sz 5 Cem	603	7	0%	3.3%
Attune Rp Tib Base Sz 4 Cem	593	7	0%	3.8%
Attune Rp Tib Base Sz 7 Cem	404	7	0%	2.2%
Attune Rp Tib Base Sz 6 Cem	385	14	0.3%	2.8%
Mbt Cem Keel Tib Tray Sz5	356	3	0%	1.3%
Pfc Sigmarp Stb Tb In 4 10 0	315	5	0%	0.6%
Nexgen Lps-Flex Femoral Component	302	0	0%	4.8%
Mbt Cem Keel Tib Tray Sz2	289	3	0%	0.3%
Pfc Sigmarp Stb Tb In 3 10 0	280	2	0%	0%
Attune Rp Tib Base Sz 8 Cem	264	4	0%	1.9%
Unknown Knee Tibial Insert	253	130	0.2%	2.2%
Attune Rp Tib Base Sz 3 Cem	246	2	0%	15.1%
Lcs Comp Rp Insert Lg 10mm	236	1	0%	0.4%
Pfc Sigmarp Stb Tb In 5 10 0	218	0	0%	0%
UNK Attune Knee Tibial Insert	207	102	0.1%	0.2%
Lcs Comp Rp Insert Std+ 10mm	205	3	0%	0.5%
Lcs Comp Rp Insert Std 10mm	202	7	0%	1.5%
Pfc Sigmarp Stb Tb In 4 12 5	186	0	0%	0.5%
Pfc Sigmarp Cv Tb/In S3 10 0	168	2	0%	0.6%
Attune Ps Rp Insrt Sz6 5mm	164	16	0%	0.5%
Mbt Revision Cem Tib Tray Sz 4	161	0	0%	1.2%
Mbt Revision Cem Tib Tray Sz 3	157	0	0%	1.3%
Unknown Knee Tibial Tray	157	57	0.2%	3%
Mbt Cem Tibial Tray Sz3	154	0	0%	0%
Attune Ps Rp Insrt Sz5 5mm	152	2	0%	3.3%
Pfc Sigmarp Stb Tb In 3 12 5	152	1	0%	0%
UNK Knee Tibial Insert Sigma	148	57	0%	1.5%

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
Depuy Ireland - 9616671	7,191	27.6%
Depuy Orthopaedics US	5,745	22.1%
Depuy Ireland 9616671	2,551	9.8%
Depuy Orthopaedics	2,005	7.7%
Depuy Orthopaedics 1818910	1,425	5.5%
Depuy Ireland	1,173	4.5%
Depuy-Cork A Division Of Depuy Orthopaedics	914	3.5%
9616671 Depuy Ireland	517	2%
Zimmer	470	1.8%
Depuy Warsaw	413	1.6%
Depuy-Raynham A Division Of Depuy Orthopaedics	304	1.2%
1219655 Depuy-Raynham A Div Of Depuy Orthopaedic	270	1%
1818910 Depuy Orthopaedics	270	1%
Depuy Ireland Reg 9616671	269	1%
Depuy Raynham	224	0.9%

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%7

Injury96.8%25,207

Malfunction3.2%821

Other0%4

Not given0%7

Who filed

Manufacturer report99.8%26,003

Voluntary report0.2%40

User facility report0%0

Distributor report0%1

Not given0%2

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

Device problems coded

Device problem (FDA code)	Reports	Share
Insufficient device problem information	5,150	19.8%
Loss of or failure to bond	4,794	18.4%
Implant, removal of	1,828	7%
Naturally worn	1,506	5.8%
Loose	583	2.2%
Migration or expulsion of device	499	1.9%
Loss of osseointegration	445	1.7%
Migrationthe device moved from where it was placed	415	1.6%
Component(s), worn	357	1.4%
Loose or intermittent connection	286	1.1%
Malposition of device	264	1%
Unintended movement	247	0.9%
Device dislodged or dislocated	241	0.9%
Osseointegration problem	234	0.9%
Fracturea broken bone	230	0.9%
Breakthe device broke	211	0.8%
Other (for use when an appropriate device code cannot be identified)	207	0.8%
Noise, audible	145	0.6%
Inadequacy of device shape and/or size	135	0.5%
Explanted	116	0.4%

Questions about prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing reports

What is product code NJL?

FDA's classification code for "Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

26,046 reports through August 2026, 929 of them in the latest 12 months.

Which brands appear most often?

Mbt Cem Keel Tib Tray Sz3 (1,028), Mbt Cem Keel Tib Tray Sz4 (616), Mbt Cem Keel Tib Tray Sz2 5 (615), Attune Rp Tib Base Sz 5 Cem (603) and Attune Rp Tib Base Sz 4 Cem (593). 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.