PatellaRecalls & reported problems across all models

We found 4 models of Patella by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2019 and Oct 13, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Malposition of Device” (2 reports).

5 FDA recall records name at least one of these models by its device identifier, 5 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Patella recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 30, 2026Open, Classified

   Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

   Z-3197-2026 · Root cause: Process change control · Recall details · FDA record ↗

2. Dec 1, 2023Open, Classified

   Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

   Z-0872-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. Dec 1, 2023Open, Classified

   Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

   Z-0871-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

4. Dec 1, 2023Open, Classified

   Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

   Z-0870-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

5. Dec 1, 2023Open, Classified

   Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

   Z-0869-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported Patella problems

Patella models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Patella 3044-0026

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 recalls0 reports
• Patella 3044-0028

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 recall3 reports
• Patella 3044-0030

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 recall0 reports
• Patella 3044-0032

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 recall0 reports

Recent Patella adverse event reports

The 3 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryOct 13, 2023Malposition of Device; Malposition of Device

  THE PATIENT UNDERWENT ARTHROSCOPIC EXAM, DEBRIDEMENT OF THE SYNOVIUM, AND LATERAL RELEASE TO ADDRESS PATELLAR IMPINGEMENT. NO DEVICES WERE REVISED.

  Patient problems: Synovitis

  MAUDE report 17928591 ↗
• InjuryMay 28, 2021Malposition of Device; Malposition of Device

  IN PERFORMING FOLLOW-UP FOR A PI, REP PROVIDED A REVISION OPERATIVE REPORT FOR (B)(6) 2013 FOR THE PATIENT'S RIGHT KNEE. PREOPERATIVE DIAGNOSIS: LOOSE RIGHT REVISION KNEE ARTHROPLASTY WITH MALTRACKING OF PATELLA. OP REPORT NOTES: "IN LESS THAN 1 YEAR SHE DEVELOPED INCREASING PAIN AND DISCOMFORT. STUDIES ARE SUSPICIOUS FOR POSSIBLE LOOSENING OF FEMORAL COMPONENT. THERE WAS ONLY SOME DISTAL CEMENT AROUND THE FEMORAL COMPONENT. THE STEM APPEARED TO BE REACTIVE LINE AROUND IT SUGGESTING LOOSENING OF FEMORAL COMPONENT...THE PATELLA WAS ALSO TILTING AND MALTRACKING¿FEMORAL COMPONENT CAME OUT VERY EASILY WITH NO FIXATION AT ALL. THE CEMENT WAS BONDED TO THE IMPLANT WITH AUGMENTS. THE STEM CAME OUT AND THERE WAS A FIBROUS MEMBRANE AROUND THE STEM COMPLETELY. THERE WAS NO CEMENT ON THE STEM AT ALL CONSISTENT WITH FEMORAL COMPONENT LOOSENING...WE HAD TO REMOVE THE PATELLAR COMPONENT TO POSITION IT MORE CENTRALLY..."

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 11900264 ↗
• InjuryJun 11, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "PAINFUL RIGHT TOTAL KNEE ARTHROPLASTY 2008 SECONDARY TO FLEXION INSTABILITY AND LOOSENING OF THE TIBIAL COMPONENT. SEVERE POLYETHYLENE WEAR LATERAL TIBIAL PLATEAU OF THE ARTICULAR COMPONENT WITH ASSOCIATED SYNOVITIS".

  Patient problems: Injury; Pain; Synovitis

  MAUDE report 8686457 ↗

Other Howmedica Osteonics Corp. products

• Triathlon608 models · 3,524 reports · 15 recalls
• Scorpio107 models · 113 reports · 28 recalls
• Trident160 models · 1,280 reports · 2 recalls
• Accolade57 models · 1,228 reports
• Duracon58 models · 65 reports · 16 recalls
• LFIT23 models · 852 reports
• TRIDENT II42 models · 188 reports · 12 recalls
• INSTRUMENT131 models · 290 reports · 7 recalls