ATTUNE 1517-00-708Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295055037), received between Oct 15, 2020 and Nov 6, 2024 — 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.

• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ENTRAPMENT RAMUS INFRAPATELLARIS DEVICE AND PROCEDURE (RELATEDNESS) REMOTE POSSIBILITY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF EVENT: UNK DECEMBER 2020 DATE OF IMPLANT: NO INFORMATION PROVIDED DATE OF REVISION: (B)(6) 2019 DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: FULL KNEE REVISION USING ATTUNE PS FB DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150440207 LOT NUMBER ID: HF5013 COMPONENT TYPE: FEMORAL COMPONENT DEVICE IDENTIFIER: (B)(4) CATALOG NUMBER: 151312060 LOT NUMBER ID: J06U38 COMPONENT TYPE: FEMORAL STEM DEVICE IDENTIFIER: (B)(4) CATALOG NUMBER: 151304000 LOT NUMBER ID: 8710875 COMPONENT TYPE: FEMORAL STEM OFFSET ADAPTOR DEVICE IDENTIFIER: (B)(4) CATALOG NUMBER: 154707002 LOT NUMBER ID: HW2120 COMPONENT TYPE: FEMORAL MEDIAL DISTAL AUGMENT DEVICE IDENTIFIER: (B)(4) CATALOG NUMBER: 154707002 LOT NUMBER ID: HW2120 COMPONENT TYPE: FEMORAL LATERAL DISTAL AUGMENT DEVICE IDENTIFIER: (B)(4) CATALOG NUMBER: 154907001 LOT NUMBER ID: J0504F COMPONENT TYPE: FEMORAL MEDIAL POSTERIOR AUGMENT DEVICE IDENTIFIER: (B)(4) CATALOG NUMBER: 154907002 LOT NUMBER ID: H78959 COMPONENT TYPE: FEMORAL LATERAL POSTERIOR AUGMENT DEVICE IDENTIFIER:

  Patient problems: Nerve Damage

  MAUDE report 20624132 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ENTRAPMENT RIGHT INFRAPATELLARIS KNEE RIGHT EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE THERE IS A REMOTE POSSIBILITY THAT THE EVENT IS RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019 DATE OF EVENT (ONSET): (B)(6) 2020 (RIGHT KNEE), TREATMENT: NONE.

  Patient problems: No Code Available

  MAUDE report 10684754 ↗

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-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-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-2348-2021 · Jul 1, 2021 · Terminated
  ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
• Z-1704-2018 · Apr 16, 2018 · Terminated
  ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
• Z-1703-2018 · Apr 16, 2018 · Terminated
  ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee