Avon 6430-0-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327049305), received between Oct 16, 2018 and Feb 21, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

8 other recalls cover devices cleared under the same FDA submission (K041160, K051948, K052917, K211303, K242831); 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 18, 2026.

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.

• InjuryFeb 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "THE PATIENT EXPERIENCED A LOT OF PAIN WHEN STANDING UP, SITTING DOWN, AND WHEN WALKING. THE PATELLA IMPLANT FAILED TO TRACK PROPERLY ON THE AVON PATELLOFEMORAL COMPONENT. WE CONVERTED INTO A PRIMARY PS TRIATHLON KNEE". REP REPORTED THAT HOSPITAL WOULD NOT RELEASE X-RAYS TO STRYKER.

  Patient problems: Pain

  MAUDE report 8357503 ↗
• InjuryNov 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: PATIENT HAD PAIN WITH PATELLOFEMORAL COMPONENT. SURGEON REMOVED COMPONENT AND IMPLANTED TRIATHLON TOTAL KNEE. NO COMPLICATIONS.

  Patient problems: Injury; Pain

  MAUDE report 8046051 ↗
• InjuryOct 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT UNDERWENT AN AVON PATELLO-FEMORAL ARTHROPLASTY (B)(6) 2014. PATIENT REQUIRED A REVISION/CONVERSION TO A TKA ON (B)(6) 2018, DUE TO PAIN.

  Patient problems: Injury; Pain

  MAUDE report 7969796 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041160, K051948, K052917, K211303, K242831. One submission often covers many models, so check the product and lot details in each record.

• Z-3206-2026 · Jul 30, 2026 · Open, Classified
  SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910 Orthopaedic implant components manufactured from UHMWPE (polyet
• Z-0893-2024 · Dec 1, 2023 · Open, Classified
  SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110
• Z-0896-2024 · Dec 1, 2023 · Open, Classified
  SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3708
• Z-0897-2024 · Dec 1, 2023 · Open, Classified
  SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710
• Z-0900-2024 · Dec 1, 2023 · Open, Classified
  Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0910
• Z-0895-2024 · Dec 1, 2023 · Open, Classified
  SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3508
• Z-0894-2024 · Dec 1, 2023 · Open, Classified
  SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308
• Z-0606-2012 · Aug 17, 2011 · Terminated
  Eius Unicompartmental Knee System Stryker Howmedica Osteonics Corp. Howmedica International S. de R.L., Raheen Business Park, Limerick, Ireland. Intended for use in Unicompartment