ATTUNE 1516-20-508Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10603295045670), received between Dec 21, 2018 and Aug 11, 2026 — classified as 27 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that poly was replaced due to possible infection.DOI: (b)(6) 2020.DOR: (b)(6) 2026.Affected Side: Right Knee.

  Patient problems: Unspecified Infection

  MAUDE report 50208801 ↗
• MalfunctionJul 21, 2026Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25893841 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POLY SWAP FROM INFECTION. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23050853 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PROBABLE INFECTION. I&D AND POLY EXCHANGE WAS PERFORMED. DOI: ON (B)(6) 2022, DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 18756912 ↗
• InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO CHRONIC INFECTION. UPON VISUAL INSPECTION THERE WERE NO DEFICIENCIES. NONE OF IMPLANTS WERE BROKEN. THERE WAS NO TIME ADDITIONAL TIME ADDED TO THE CASE. IMPLANTS WERE PUT IN 2014. SALES REP DO NOT HAVE AN EXACT DATE. THERE WAS NO SURGICAL DELAY, DOI- 2014. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16426154 ↗
• InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A SUCCESSFUL LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016 UTILIZING DEPUY IMPLANTS INCLUDING PATELLA AND CEMENT X2. PATIENT WAS LATER REVISED ON (B)(6) 2021 FOR SWELLING, PAIN, AND XRAYS SUGGESTIVE OF RADIOLUCENCIES UNDER THE MEDIAL TIBIAL PLATE. INTRAOPERATIVELY, THE SYNOVIUM WAS GRAY AND HYPERTROPHIC ¿CONSISTENT WITH CEMENT DEBRIS SYNOVITIS¿ BUT ¿NO SIGNIFICANT POLY WEAR.¿ THE TIBIAL PLATE WAS COMPLETELY DEBONDED FROM THE CEMENT. THERE WAS OSTEOLYSIS ALONG THE FEMORAL CONDYLE AND MEDIAL TIBIA. THE FEMORAL AND PATELLAR COMPONENTS WERE WELL FIXED AND NOT REVISED. DOI: (B)(6) 2016. DOR: (B)(6) 2021 (TIBIAL TRAY AND INSERT - LEFT KNEE).

  Patient problems: Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 15876666 ↗
• InjuryFeb 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INSTABILITY AND SUSPECTED INFECTION. BASEPLATE WAS LOOSE, WHICH WAS DISCOVERED IN SURGERY.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 13543875 ↗
• InjuryFeb 16, 2022Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT FELL A DEVELOPED A CLICKING NOISE IN HER KNEE AND A LOOSING OF HER SOFT TISSUES TO THE POINT IT FELT UNSTABLE TO HER. A FULL REVISION WAS COMPLETED. NONE OF THE COMPONENTS WERE LOOSE. THE PATELLA WAS LEFT INTACT. THE END RESULT WAS THE PATIENT HAD A FULL RANGE OF MOTION FROM FLEXION TO EXTENSION. NO FURTHER INFORMATION IS AVAILABLE ABOUT THIS CASE. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE AFFECTED.

  Patient problems: Fall; Joint Laxity

  MAUDE report 13542600 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LOWER RESPIRATORY TRACT INFECTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: UNKNOWN. DATE OF EVENT (ONSET): (B)(6) 2022 (UNKNOWN KNEE). TREATMENT: UNSPECIFIED INJECTED AND ORAL MEDICATION.

  Patient problems: Unspecified Infection

  MAUDE report 13422730 ↗
• InjuryFeb 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ,CLINICAL ADVERSE EVENT RECEIVED FOR SEVERE POST OPERATIVE PAIN. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: UNKNOWN, DATE OF EVENT (ONSET): (B)(6) 2022, (UNKNOWN KNEE). TREATMENT: UNSPECIFIED INJECTED MEDICATION, UNSPECIFIED ORAL MEDICATION, AND FEMORAL NERVE BLOCK.

  Patient problems: Pain

  MAUDE report 13415711 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT FELL POST OP AND SPLIT INCISION OPEN. THE PATIENT WAS TREATED NON-OPERATIVELY PREVIOUSLY AND WOULD NOT CLEAR STAPH INFECTION. A HOFFMAN SPACER WAS PLACED. DOI: (B)(6) 2021 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Fall; Unspecified Infection; Wound Dehiscence

  MAUDE report 13046222 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WASHOUT WAS PERFORMED DUE TO INFECTION. NEW INSERT WAS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2021, (RIGHT KNEE).

  Patient problems: Unspecified Infection

  MAUDE report 13043250 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED INDICATED THAT THE CEMENT USED WAS MANUFACTURED BY STRYKER ORTHOPEDICS. DEPUY IMPLANTS WERE USED AS A MOLD TO KEEP THE JOINT MOBILE.

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

  MAUDE report 11842348 ↗
• InjuryFeb 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTED KNEE. REMOVED TIBIAL INSERT, WASHED OUT KNEE AND REINSERTED NEW TIBIAL INSERT. DOR: (B)(6) 2021.

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

  MAUDE report 11321374 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT RECEIVED A DEPUY RIGHT TOTAL KNEE REPLACEMENT, TO ADDRESS OSTEOARTHRITIS. THE KNEE WAS A CEMENTED TIBIAL AND FEMORAL CONSTRUCT, WITH A FIXED BEARING INSERT. THE PATELLA WAS ALSO RESURFACED AND TWO BATCHES OF DEPUY CEMENT WERE USED THROUGHOUT. THE SURGEON REPORTED THAT THE PROCEDURE WAS TOLERATED WELL WITHOUT ANY MAJOR COMPLICATIONS. ON (B)(6) 2020, THE PATIENT'S RIGHT KNEE WAS REVISED TO ADDRESS PAIN, ASEPTIC LOOSENING OF THE TIBIAL BASEPLATE AT THE CEMENT TO IMPLANT INTERFACE, AND MEDIAL COLLATERAL LIGAMENTOUS INSTABILITY. IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED PAIN SINCE HIS PRIMARY. ALL INFECTION MARKERS WERE NEGATIVE, WHILE A BONE SCAN ON (B)(6) 2019 SHOWED TIBIAL UPTAKE, SUGGESTING ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. THE PATIENT ALSO DEMONSTRATED ON EXAMINATION, THAT HE HAD A SIGNIFICANT AMOUNT OF MID FLEXION INSTABILITY, PARTICULARLY WITH VALGUS STRESS, INDICATING LAXITY OF THE MEDIAL COLLATERAL LIGAMENT. INTRAOPERATIVELY, SURGEON NOTED THAT THERE WAS CHRONIC APPEARING SYNOVITIS. THE FEMORAL COMPONENT WAS WELL FIXED, WHILE THE TIBIAL TRAY WAS NOT WELL FIXED TO THE CEMENT MANTLE. THE CEMENT MANTLE, ON THE OTHER

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Pain; Synovitis

  MAUDE report 11087940 ↗
• InjuryNov 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A BILATERAL KNEE REVISION WITH IRRIGATION AND DEBRIDEMENT WITH TIBIAL INSERT EXCHANGE OF BOTH KNEES TO ADDRESS INFECTION. THE PATIENT WAS ALSO EXPERIENCING PAIN AND SWELLING. DOI: (B)(6) 2019, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Swelling/ Edema

  MAUDE report 10914477 ↗
• InjurySep 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. WASHOUT AND POLY SWAP WERE DONE. DOI: (B)(6) 2020. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10554107 ↗
• InjuryAug 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS JOINT RANGE OF MOTION DECREASED OF 10-60 DEGREES. THE PATIENT HAD NATURAL PATELLA BAJA AND WAS REVISED TO TC3 CONSTRUCT. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT KNEE.

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

  MAUDE report 10450010 ↗
• InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMMUNICATION RECEIVED. IT WAS REPORTED THAT PATIENT HAD A TOTAL KNEE ON (B)(6) 2018, HAD A REVISION ON (B)(6) 2018 DUE TO WOBBLING, SWELLING AND PAIN. DOI: (B)(6) 2018; DOR: (B)(6) 2018 (UNKNOWN SIDE).

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

  MAUDE report 9829598 ↗
• InjuryFeb 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO ALLEGED PAIN. NO SURGICAL DELAY NOTED. DOI: (B)(6) 2018. DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9677781 ↗
• InjuryJan 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2016; DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9624884 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT UNDERWENT A LEFT KNEE REVISION OF A POLY EXCHANGE DUE TO FLEXION INSTABILITY. THE SURGEON REPORTED THE COMPONENTS APPEARED TO BE WELL-PLACED AND WELL-FIXED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. DOI: (B)(6) 2013; DOR: (B)(6) 2014; (RT KNEE).

  Patient problems: No Code Available

  MAUDE report 9552961 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. TIBIAL INSERT EXCHANGED STATUS POST WASH OUT. DOI: (B)(6) 2019. DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9520658 ↗
• MalfunctionOct 31, 2019Difficult to Insert; Inadequacy of Device Shape and/or Size; Difficult to Insert; Inadequacy of Device Shape and/or Size

  CR FB INSERT WAS NOT ENGAGING INTO LOCKING MECHANISM. HAD TO OPEN ANOTHER INSERT INTRAOPERATIVELY. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9260853 ↗
• InjuryOct 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT UNDERWENT A RIGHT KNEE POLYETHYLENE EXCHANGE DUE TO INFECTION AND TENOSYNOVITIS. THE SURGEON REPORTED THE INSERT POLY WAS REMOVED AND REPLACED WITH POLY OF SIMILAR SIZE. THE PATIENT WAS IMPLANTED WITH DEPUY TIBIAL INSERT AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2016 (TIBIAL AND FEMORAL COMPONENTS); DOI: (B)(6) 2018 (INSERT); DOR: (B)(6) 2018.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9217825 ↗