ATTUNE 1517-00-512Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295054832), received between May 26, 2021 and Jun 14, 2021 — classified as 2 injuries.

5 other recalls cover devices cleared under the same FDA submission (K160700, K241000); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR MID TO DISTAL ANTERIOR THIGH PAIN ON (B)(6) 2017, THE PATIENT HAD A REVISED TOTAL RIGHT KNEE TO ADDRESS INSTABILITY. DEPUY COMPONENTS ALONG WITH COMPETITOR CEMENT X2, WERE IMPLANTED DURING THIS PROCEDURE.. (B)(6) 2019 MEDICAL RECORDS NOTE THAT THE PATIENT PRESENTS WITH PAIN IN RIGHT KNEE AND HIP, WITH BUCKLING AND SWELLING OF THE RIGHT KNEE. LEFT KNEE PAIN DUE TO OA CHANGES (NATURAL KNEE). PATIENT IS DOING PHYSICAL THERAPY DATE OF IMPLANTATION: (B)(6) 2017. DATE OF EVENT (ONSET): (B)(6) 2018. (RIGHT KNEE) TREATMENT: PHYSICAL THERAPY

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 11992863 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE INSTABILITY. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2017, DATE OF EVENT (ONSET): (B)(6) 2018, (RIGHT KNEE). TREATMENT: PHYSICAL THERAPY & KNEE BRACE.

  Patient problems: Joint Laxity

  MAUDE report 11885654 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160700, K241000. One submission often covers many models, so check the product and lot details in each record.

• Z-0632-2022 · Jan 5, 2022 · Terminated
  ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154706001
• Z-0631-2022 · Jan 5, 2022 · Terminated
  ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003
• Z-2348-2021 · Jul 1, 2021 · Terminated
  ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
• Z-1703-2018 · Apr 16, 2018 · Terminated
  ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
• Z-1704-2018 · Apr 16, 2018 · Terminated
  ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee