ATTUNE 1516-40-512Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295049975), received between Aug 28, 2018 and Sep 29, 2022 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2019. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 15508519 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2020, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 13017648 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 13009309 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2020, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12862258 ↗
• InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INFECTION. WASH OUT AND POLY EXCHANGED WAS DONE. NO LOOSENING AND NO DELAY IN SURGERY REPORTED. DOI: (B)(6) 2019. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11805670 ↗
• MalfunctionJan 29, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE LOCKING MECHANISM ON POLY DAMAGE DURING IMPLANTATION. SURGICAL DELAY OF 1 MINUTE. ED: (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 11252300 ↗
• InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED DUE TO PAIN. NO SURGICAL DELAY. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 10889310 ↗
• InjuryFeb 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED IN CLINIC WITH A ¿WOBBLY¿ RIGHT KNEE. UPON EXAMINATION SURGEON FELT THE PATIENT¿S KNEE HAD TOO MUCH VARUS/ VALGUS PLAY AND ELECTED TO REVISE THE INDEX ARTHROPLASTY WHICH WAS IMPLANTED AT PHYSICIAN¿S CARE SURGICAL HOSPITAL IN (B)(6) BY SURGEON ON (B)(6) 2018. ON TUESDAY, (B)(6) 2020 SURGEON REVISED PATIENT¿S KNEE AT THE (B)(6) HOSPITAL. UPON EXPOSURE TO THE JOINT SURGEON REMOVED THE INDEX FEMUR AND POLY INSERTED AND ELECTED TO KEEP THE INDEX TIBIA AND PATELLA. NO IMPLANTS WERE FOUND TO BE LOOSE; ALL WERE WELL FIXED. NO INSTRUMENTATION BROKE DURING SURGERY. THERE WERE NO TIME DELAYS. SURGEON DID NOT THINK THAT ANY PRODUCT DID NOT PERFORM AS IT WAS SUPPOSE TO. SURGEON IMPLANTED A REVISION FEMORAL COMPONENT WITH A PRESS FIT STEM AND DISTAL ARGUMENTS. HE ALSO IMPLANTED A REVISION TIBIAL INSERT.

  Patient problems: No Code Available

  MAUDE report 9676224 ↗
• InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. CULTURED IS POSITIVE FOR ENTEROBACER. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9409958 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2016; DOR: (B)(6) 2019 LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9210034 ↗
• InjuryMay 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8658059 ↗
• InjuryAug 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: PATIENT WAS REVISED TO ADDRESS A TORN EXTENSOR MECHANISM AND COMPROMISED MCL. TIBIAL LOOSENING AT THE CEMENT/IMPLANT INTERFACE WAS ALSO REPORTED. THE CEMENT MANUFACTURER IS UNKNOWN.

  Patient problems: Not Applicable; Pain; Synovitis

  MAUDE report 7823928 ↗

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