ATTUNE 1516-40-310Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295049685), received between Nov 5, 2019 and Jun 21, 2023 — classified as 6 injuries.

1 other recall cover devices cleared under the same FDA submission (K111433, K233980); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECT SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17170244 ↗
• InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2022, DOI: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16794998 ↗
• InjuryOct 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A LEFT ATTUNE TOTAL KNEE TO TREAT ARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO ADDRESS PAIN, FALL, SWELLING, INSTABILITY, SCAR TISSUE, OSTEOPHYTES, AND TIBIAL TRAY LOOSENING AT AN UNKNOWN INTERFACE. PREVIOUS PLATE AND SCREWS IMPLANTED DUE TO PRIOR DISTAL FEMORAL BONE FRACTURE WERE REMOVED BY A SECOND INCISION. THE PLATES AND SCREWS REMOVED WERE FROM AN UNKNOWN MANUFACTURER. THE SURGEON SUSPECTED OSTEOMYELITIS AND SENT SAMPLES WITH NO RESULTS GIVEN. THE TIBIAL INSERT, TIBIAL TRAY, AND FEMORAL COMPONENT WERE REVISED. THE PATELLA COMPONENT WAS RETAINED. THE PATIENT WAS REVISED WITH DEPUY PRODUCTS AND CEMENT X 2. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2015; DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Fall; Joint Laxity; Pain; Scar Tissue; Swelling/ Edema; Unspecified Infection

  MAUDE report 12682950 ↗
• InjuryOct 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. PATELLA WAS REVISED AND POLY INSERT WAS REPLACED ALSO. ALL COMPONENTS WERE FOUND TO BE WELL FIXED. DOI: (B)(6) 2019. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Pain

  MAUDE report 12647185 ↗
• InjuryJan 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO INSTABILITY. THE PREVIOUSLY UNRESURFACED PATELLA WAS RESURFACED DURING THE OPERATION. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. ALL PRODUCTS WERE REVISED. DOI: (B)(6) 2014; DOR: (B)(6) 2015 RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9582287 ↗
• InjuryNov 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 10 OCTOBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2015, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO END STAGE DEGENERATIVE ARTHRITIS AND PAIN. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH DEPUY KNEE SYSTEM AND DEPUY BONE CEMENT X 2. ON (B)(6) 2016, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO INSTABILITY AND EFFUSIONS. THE SURGEON REPORTED THE FEMORAL, TIBIAL, AND PATELLAR COMPONENTS WERE NOTED TO BE WELL ALIGNED AND WELL FIXED, AND THERE WAS NO EVIDENCE OF INFECTION. HE INDICATED HE UPSIZED THE POLY INSERT. THERE WERE NO REPORTED COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2015, DOR: (B)(6) 2016 (RT KNEE).

  Patient problems: Edema; No Code Available

  MAUDE report 9280242 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111433, K233980. One submission often covers many models, so check the product and lot details in each record.

• Z-1267-2023 · Feb 15, 2023 · Open, Classified
  Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507