Patella 3044-0028Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327033793), 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).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K863668); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. 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 ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K863668. One submission often covers many models, so check the product and lot details in each record.

• Z-0869-2024 · Dec 1, 2023 · Open, Classified
  SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026
• Z-0871-2024 · Dec 1, 2023 · Open, Classified
  SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0030
• Z-0872-2024 · Dec 1, 2023 · Open, Classified
  SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032