ATTUNE 1506-80-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295492146), received between Jun 1, 2020 and Feb 13, 2025 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (5 reports).

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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT KNEE REVISION FOR PAIN AND SUSPICIOUS SPECT-CT. THE PATIENT REQUIRES REVISION SURGERY OR HARDWARE REMOVAL.

  Patient problems: Pain

  MAUDE report 21375064 ↗
• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON APRIL 26, 2021, THE PRIMARY SURGERY WAS PERFORMED VIA TKA WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, DUE TO INFECTION. THE CAUSE OF THE INFECTION WAS AN ABRASION ON THE FOOT THAT WAS LEFT UNTREATED AND BECAME SWOLLEN. THE TREATMENT FOR INFECTION WAS REMOVAL OF THE IMPLANTS AND PLACEMENT OF AN ANTIBIOTIC CEMENT MOLD. THE PATERA WAS NOT EXTRACTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 16752706 ↗
• MalfunctionNov 4, 2021Off-Label Use; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping; Off-Label Use; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT IT WAS CONFIRMED THAT THERE WERE TRACES OF DIRT AND PROTECTIVE COVERS ON THE SURFACE OF THE TRAY. THE TRAY WAS USED AS IT WAS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE ADVERSE EVENT TO THE PATIENT IS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12750710 ↗
• MalfunctionNov 1, 2021Off-Label Use; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping; Off-Label Use; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE TKA SURGERY FOR RA WITH THE TIBIAL TRAY IN QUESTION. DURING THE SURGERY, IT WAS CONFIRMED THAT THERE WERE TRACES OF DIRT AND PROTECTIVE COVERS ON THE SURFACE OF THE TRAY. THE TRAY WAS USED AS IT WAS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE ADVERSE EVENT TO THE PATIENT IS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12728625 ↗
• MalfunctionSep 21, 2021Off-Label Use; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping; Off-Label Use; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE TKA SURGERY FOR OA WITH THE TIBIAL TRAY IN QUESTION. DURING THE SURGERY, IT WAS CONFIRMED THAT THERE WERE TRACES OF DIRT AND PROTECTIVE COVERS ON THE SURFACE OF THE TRAY. THE SURGEON WIPED THE TRAY WITH A GAUGE, AND IT WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE ADVERSE EVENT TO THE PATIENT IS NOT REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12506008 ↗
• MalfunctionJul 9, 2021Off-Label Use; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping; Off-Label Use; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT TKA FOR OA WITH THE TIBIAL TRAY IN QUESTION. DURING SURGERY, THE SURGEON FOUND DIRT ON THE SURFACE OF THE TIBIAL TRAY. HE DIDN'T USE THE TIBIAL TRAY AND OPENED THE NEW TIBIAL TRAY. HOWEVER, THE NEW TIBIAL TRAY ALSO HAD DIRT ON ITS SURFACE. THE SURGEON WIPED THE DIRT OFF AND USED IT. THE SURGEON FOUND THE DIRT WITHOUT TOUCHING THE SURFACE OF THE TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THERE WAS 30 MIN SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 12142473 ↗
• MalfunctionJul 9, 2021Off-Label Use; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping; Off-Label Use; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT TKA FOR OA WITH THE TIBIAL TRAY IN QUESTION. DURING SURGERY, THE SURGEON FOUND DIRT ON THE SURFACE OF THE TIBIAL TRAY. HE DIDN'T USE THE TIBIAL TRAY AND OPENED THE NEW TIBIAL TRAY. HOWEVER, THE NEW TIBIAL TRAY ALSO HAD DIRT ON ITS SURFACE. THE SURGEON WIPED THE DIRT OFF AND USED IT. THE SURGEON FOUND THE DIRT WITHOUT TOUCHING THE SURFACE OF THE TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THERE WAS 30 MIN SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 12142472 ↗
• InjuryJun 1, 2020Malposition of Device; Malposition of Device

  THE PRIMARY SURGERY WAS PERFORMED ON AN UNKNOWN DATE VIA TKA FOR THE PATIENT¿S LEFT KNEE JOINT. WHEN THE PRIMARY SURGERY, THE IMPLANT WAS SET AS MALALIGNMENT. THE SURGEON DECIDED TO PERFORM THE REVISION SURGERY BECAUSE THE PATIENT HAD A PAIN DUE TO THE IMPLANT¿S MALALIGNMENT. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE TIBIAL TRAY AND THE TIBIAL INSERT . DURING THE REVISION SURGERY, THE SURGEON JUDGED THAT THERE WAS NO LOOSENING AT THE FEMORAL COMPONENT. THE REVISION SURGERY WAS COMPLETED. THE SURGEON COMMENTED THAT THERE WAS NO CAUSAL RELATION BETWEEN THIS EVEN TO THE PRODUCTS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Pain

  MAUDE report 10105543 ↗