ATTUNE 1516-50-305Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295052142), received between Jun 7, 2019 and Mar 31, 2026 — classified as 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTED KNEE DUE TO A FALL. POLY SWAP AND WASHOUT WAS DONE. AFFECTED SIDE: UNKNOWN.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 24742966 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY AND CEMENT IS NOT FROM DEPUY SYNTHES.

  Patient problems: Pain

  MAUDE report 21375074 ↗
• InjuryJan 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INSERT REVISED DUE TO INSTABILITY. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOR: (B)(6) 2023 AFFECTED SIDE: UNKNOWN

  Patient problems: Joint Laxity

  MAUDE report 18582603 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATELLA MALRACKING AND JOINT FLEXION IS LIMITED. PATELLA OSTEOTOMIE AND RESURFACING PATELLA AND CHANGED INSERT. DOI: UNKNOWN. DOE: (B)(6). 2023. AFFECTED SIDE: ATTUNE RIGHT.

  Patient problems: Joint Laxity; Loss of Range of Motion; Unspecified Tissue Injury

  MAUDE report 17861415 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO UNSTABLE OF TOTAL RIGHT KNEE. UPSIZED TO 10MM POLY. DOI: (B)(6) 2021 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT KNEE

  Patient problems: Joint Laxity

  MAUDE report 16419249 ↗
• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA TKA FOR RIGHT KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, INFECTION WAS OCCURRED. ON (B)(6) 2022, THE PATIENT UNDERWENT THE REVISION SURGERY. IN THE REVISION SURGERY, DEBRIDEMENT AND SCRAPING, ANTIBIOTIC ADMINISTRATION, AND INSERT REPLACEMENT WERE PERFORMED. THE REOPERATION WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE SURGEON COMMENTED THAT ALTHOUGH THE CAUSE OF THE INFECTION WAS UNKNOWN, BUT THAT MRSA WAS DETECTED, AND THE IMPLANT MIGHT NEED TO BE REMOVED LATER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 15942148 ↗
• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. CEMENT MANUFACTURER WAS NOT INDICATED. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2016. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15122178 ↗
• MalfunctionMar 23, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE TKA SURGERY FOR OA. DURING THE SURGERY, AN OPERATION STAFF FOUND A HAIR INSIDE THE PACKAGE OF THE ATTUNE INSERT. THE HAIR WAS NOT FOUND IMMEDIATELY AFTER THE PACKAGE WAS OPENED. SINCE THE IMPLANT WAS PREPARED AND LEFT FOR A WHILE, THE STAFF DID NOT KNOW WHETHER THE HAIR WAS CONTAMINATED ORIGINALLY OR DURING THE SURGERY. IN THE SURGERY, ANOTHER PRODUCT OF THE SAME SIZE WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13860386 ↗
• InjurySep 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE SURGERY WITH THE INSERT. AFTER THE SURGERY, THE INFECTION WAS CONFIRMED, AND ON AN UNKNOWN DATE, THE REVISION SURGERY WAS PERFORMED. IN THE REVISION, DEBRIDEMENT WAS PERFORMED, AND THE INSERT WAS REPLACED. DOI: (B)(6) 2020. DOR: UNKNOWN, UNKNOWN SIDE.

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

  MAUDE report 12460657 ↗
• InjuryApr 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS AD (B)(6) 2021 WAS REVIEWED. ON (B)(6) 2016, THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS SEVERE DEGENERATIVE JOINT DISEASE. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA, AND COMPETITOR CEMENT WERE USED DURING THIS PROCEDURE. THERE WERE NO KNOWN COMPLICATIONS REPORTED DURING THE SURGERY. ON (B)(6) 2019, THE PATIENT HAD A REVISION OF THE RIGHT TOTAL KNEE TO ADDRESS LOOSENING OF THE TIBIAL TRAY AT THE CEMENT/IMPLANT AND AT THE CEMENT/BONE INTERFACE AND ARTHROFIBROSIS. PRIOR TO SURGERY THE PATIENT WAS NOTED TO HAVE HAD STIFFNESS AND PAIN AND HAS HAD A COUPLE OF MANIPULATIONS. THE PATIENT ALSO REPORTED HAVING LOST RANGE OF MOTION. DURING THE PROCEDURE THE SURGEON OBSERVED SIGNIFICANT AMOUNT OF SCARRING THROUGHOUT THE KNEE. THE TIBIAL TRAY AND INSERT WERE REVISED. DEPUY COMPONENTS WERE USED DURING THIS PROCEDURE ALONG WITH COMPETITOR CEMENT. DOI: (B)(6) 2016 DOR: (B)(6) 2019 (RIGHT KNEE).

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Range of Motion; Pain

  MAUDE report 11629307 ↗
• InjuryJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES (B)(6) 2016 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED, AND DEPUY CEMENT WAS UTILIZED X2. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2019 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO SUSPECTED TIBIAL LOOSENING. UPON ENTERING THE JOINT, SCAR TISSUE WAS DEBRIDED. THE TIBIAL COMPONENT WAS LOOSE AT THE CEMENT TO IMPLANT INTERFACE. THE FEMORAL AND PATELLA COMPONENT WERE NOT REVISED, NO INDICATION OF DEFICIENCIES. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2016. DOR: (B)(6) 2019; RIGHT KNEE

  Patient problems: Adhesion(s)

  MAUDE report 11148078 ↗
• InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. IT WAS STAPH AUREUS CULTURED. DOI: (B)(6) 2019; DOR: (B)(6) 2020; RIGHT KNEE.

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

  MAUDE report 11126912 ↗
• InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF FEMORAL IMPLANT. IT HAD BEEN IMPLANTED IN THE PRIMARY OPERATION IN A FLEXED POSITION LIMITING PATIENT'S ABILITY TO FULLY FLEX HER KNEE.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 10443191 ↗
• InjuryJun 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A LAX TOTAL KNEE. THE SURGEON PLANNED TO PUT IN A THICKER INSERT. THE FEMUR AND PATELLA ARE WELL FIXED AND RETAINED. THE TIBIAL TRAY CAME OUT AFTER MULTIPLE HARD HITS. THE TRAY APPEARED TO BE SOLID EVEN THOUGH THERE WAS NO CEMENT ON ITS BACKSIDE. IT WAS ALSO REPORTED THAT DURING REASSEMBLY OF THE INSTRUMENTS, IT WAS DISCOVERED THAT ONE RETAINING SPRING WAS MISSING ON THE SPACER BLOCK, AND ONE WAS SPRUNG ON THE TIBIAL INSERT TRIAL. THE MISSING SPRING WAS NOT PRESENT AND IT IS UNKNOWN WHERE IT IS. IT COULD HAVE BEEN LEFT IN THE PATIENT. THIS WAS CAPTURED IN (B)(4). DOI: (B)(6) 2016, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10212510 ↗
• InjuryFeb 5, 2020Naturally Worn; Naturally Worn

  THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN, DISCOMFORT, STIFFNESS, DECREASED RANGE OF MOTION, AND ADHESIONS. THE SURGEON NOTED TIBIAL TRAY MISPOSITIONING WITH SLIGHT OVERHANG AS WELL AS LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE FEMORAL COMPONENT WAS LOOSE AT THE BONE TO CEMENT INTERFACE WITH SLIGHT BONE LOSS OF THE LATERAL FEMORAL CONDYLE. THE SURGEON REPORTED WEAR ON BOTH THE TIBIAL TRAY AND TIBIAL INSERT. THE PATELLA COMPONENT WAS WELL-FIXED AND RETAINED. DEPUY CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2016; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Adhesion(s); Discomfort; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9672057 ↗
• InjurySep 26, 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 05 SEPTEMBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2016, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. IT WAS NOTED THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. ALL ATTTUNE KNEE COMPONENTS AND CEMENT WERE IMPLANTED IN THE PROCEDURE. ON (B)(6) 2018, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO STIFFNESS AND PAIN. THE SURGEON NOTED THE FEMORAL COMPONENT WAS WELL FIXED. HE REPORTED EXTENSIVE SUPRAPATELLAR FIBROSIS, DEBRIDED SCAR TISSUE, AND IT WAS REVISED. THERE WERE NO ALLEGATIONS AGAINST THE FEMORAL NOR TIBIAL COMPONENTS, THOUGH THEY WERE REVISED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. ALL ATTUNE COMPONENTS AND CEMENT WERE IMPLANTED IN THE REVISION. DOI: (B)(6) 2016. DOR: (B)(6) 2018, (LT KNEE).

  Patient problems: Fibrosis; No Code Available; Pain; Scar Tissue

  MAUDE report 9123762 ↗
• InjurySep 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 9075917 ↗
• InjuryJun 7, 2019Off-Label Use; Naturally Worn; Off-Label Use; Naturally Worn

  REVISION OF ATTUNE RP PS KNEE FOR SUSPECTED TIBIAL LOOSENING. TIBIA WAS NOT GROSSLY LOOSE. TIBIA WAS WELL FIXED MEDIALLY. FIXATION WAS SUSPECT LATERALLY. THE TIBIA WAS REMOVED AND REPLACED WITH AN ATTUNE REVISION RP TRAY. ALSO IT SHOULD BE NOTED THAT IT WAS FOUND THAT THERE WAS A SZ 3 RP PS INSERT MATED WITH A SZ 4N PS FEMUR.

  Patient problems: No Code Available

  MAUDE report 8678251 ↗