ATTUNE 1516-50-612Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295052616), received between Nov 6, 2017 and Dec 15, 2025 — classified as 23 injuries.

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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR BILATERAL LEG CELLULITIS - WORSE ON LEFT LEG DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: DEFINITELY NOT , PROCEDURE RELATED: POSSIBLY, DATE OF EVENT: 29 OCT 2025, DATE OF IMPLANT: (B)(6) 2024, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: OUTCOME: ONGOING.

  Patient problems: Cellulitis

  MAUDE report 23810147 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR INFECTED LEFT STUDY KNEE. DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: PROBABLY. TREATMENT/IMPACT: READMISSION ((B)(6) 2025); ARTHROSCOPY. DATE OF EVENT: 29 OCT 2025 DATE OF IMPLANT: (B)(6) 2024 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: LEFT TREATMENT/IMPACT: HOSPITALIZATION (INITIAL OR PROLONGED): YES; INJECTED MEDICATION: YES TREATMENT/IMPACT: REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE: TRUE DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150410106 LOT NUMBER: 4315735 COMPONENT TYPE: FEMORAL COMPONENT DESCRIPTION: ATTUNE P/S FEM LT SZ 6 CEM CATALOG NUMBER: 150660005 LOT NUMBER: 3733874 COMPONENT TYPE: TIBIAL BASE COMPONENT DESCRIPTION: ATTUNE REVISION TIBIAL BASE ROTATING PLATFORM SIZE 5 CEMENTED CATALOG NUMBER: 151650612 LOT NUMBER: 9493237 COMPONENT TYPE: TIBIAL INSERT COMPONENT DESCRIPTION: ATTUNE PS RP INSRT SZ 6 12MM. CATALOG NUMBER: 151820038. LOT NUMBER: 4304615. COMPONENT TYPE: PATELLA. DESCRIPTION: ATTUNE MEDIAL DOME PAT 38MM. CATALOG NUMBER: 66017569. LOT NUMBER: 67681283. COMPONENT TYPE: CEMENT. DESCRIPTION: PALACOS R+G 2X40.

  Patient problems: Unspecified Infection

  MAUDE report 23767583 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR PAIN, REDNESS AND SWELLING IN STUDY KNEE. DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 29 OCT 2025. DATE OF IMPLANT: (B)(6) 2024. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: INJECTED MEDICATION. CLINICAL ADVERSE EVENT RECEIVED FOR PAIN, REDNESS AND SWELLING IN STUDY KNEE. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: PROBABLY. TREATMENT: HOSPITALIZATION (INITIAL OR PROLONGED): YES, REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE: YES, READMISSION: (B)(6) 2025. DEPUY SYNTHES PRODUCTS USED: DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150410106. LOT NUMBER: 4315735. COMPONENT TYPE: FEMORAL COMPONENT. DESCRIPTION: ATTUNE P/S FEM LT SZ 6 CEM. CATALOG NUMBER: 150660005. LOT NUMBER: 3733874. COMPONENT TYPE: TIBIAL BASE COMPONENT. DESCRIPTION: ATTUNE REVISION TIBIAL BASE ROTATING PLATFORM SIZE 5 CEMENTED. CATALOG NUMBER: 151650612. LOT NUMBER: 9493237. COMPONENT TYPE: TIBIAL INSERT COMPONENT. DESCRIPTION: ATTUNE PS RP INSRT SZ 6 12MM. CATALOG NUMBER: 151820038. LOT N

  Patient problems: Erythema; Pain; Swelling/ Edema

  MAUDE report 23767220 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME TO ER WITH A WARM SWOLLEN KNEE ROUGHLY A YEAR POST REVISION TKA. PATIENT HAD BEEN PREVIOUSLY ADMITTED TO THE HOSPITAL FOR ALMOST A MONTH DUE TO AN INFECTION IN ANOTHER AREA AND SURGEON SUSPECT A HEMATOGENOUS INFECTION HAD OCCURRED IN KNEE. LABS ARE INDICATIVE OF INFECTION. PATIENT WAS BROUGHT TO THE OR FOR A THOROUGH I&D WITH INSERT EXCHANGE AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. CULTURES ARE SENT AND GROSS PUSS IS NOTED, ESSENTIALLY CONFIRMING INFECTION. NO DELAY WAS NOTED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 22139835 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION AND NEEDED NEW POLY. THE SURGICAL DELAY IS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21315755 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 21114733 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AND I&D FI WITH POLY SWAP WITH SUSPECTED INFECTION. THERE WAS NO WAY TO CONFIRM INFECTION. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19939491 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19270546 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED. STATING, THAT THE IRRIGATION AND DEBRIDEMENT WERE FOR POSSIBLE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19127580 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED RIGHT KNEE. REMOVAL OF IMPLANTS AND SPACER PLACEMENT WAS PERFORMED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17611958 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. DATE OF IMPLANT: (B)(6) 2017. DATE OF REVISION: (B)(6) 2020. (LEFT KNEE). TREATMENT: INSERT WAS REVISED.

  Patient problems: Joint Laxity

  MAUDE report 17190422 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL KNEE. THERE WAS NO SURGICAL DELAY. THERE WAS NO LOOSENING REPORTED. DOI: UNKNOWN . DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 16806212 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTED KNEE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SITE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16419235 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 14473461 ↗
• InjuryMar 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. A WASHOUT AND A POLY SWAP WERE PERFORMED. DOI: (B)(6) 2021; DOR: (B)(6) 2021; RIGHT KNEE.

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

  MAUDE report 11531700 ↗
• InjuryJul 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. THICKER POLY WAS IMPLANTED. DOI: (B)(6) 2017, DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10315160 ↗
• InjuryMay 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS SUSPECTED INFECTION. THE PATIENT HAD BI-LATERAL KNEE REPLACEMENT DONE ON (B)(6) 2019. THE PATIENT DEVELOPED A SUSPECTED INFECTION IN HIS RIGHT KNEE. THE SURGEON CONTACTED THE SALES REP AND TOLD HIM HE WANTED TO DO AN I&D AND POLY EXCHANGE. THE SURGEON REMOVED THE POLY, WASHED OUT THE KNEE, PUT IN STIMULAN BEAD, AND THEN OPENED THE SAME SIZE INSERT, IMPLANTED, AND CLOSED. DOI: (B)(6) 2019; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10034703 ↗
• InjuryMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION OF TOTAL KNEE. AN AGGRESSIVE INCISION AND DRAINAGE (I&D) WAS PERFORMED AND THE POLY WAS EXCHANGED. DOI: (B)(6) 2020. DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9780315 ↗
• InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO END-STAGE OSTEOARTHRITIS. 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) 2018 THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, LIGAMENTOUS LAXITY, AND PAIN. THE SURGEON REPORTED THE TIBIAL COMPONENT WAS GROSSLY UNSTABLE AND THERE WAS NO CEMENT ON THE COMPONENT. THE FEMORAL AND PATELLAR COMPONENTS WERE NOT REVISED. THE PATIENT WAS IMPLANTED WITH DEPUY KNEE COMPONENTS AND DEPUY BONE CEMENT. THERE WERE NO COMPLICATIONS REPORTED. DOI: (B)(6) 2016; DOR: (B)(6) 2018 (RT KNEE).

  Patient problems: No Code Available; Pain

  MAUDE report 9317292 ↗
• InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO END-STAGE OSTEOARTHRITIS 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) 2017, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO INSTABILITY, STIFFNESS, SWELLING, LIGAMENTOUS LAXITY, AND PAIN. THE SURGEON INDICATED THE TIBIAL COMPONENT WAS LOOSE AND THERE WAS NO CEMENT ON THE TIBIAL COMPONENT. DUE TO TIBIAL LOOSENING AND NEED FOR REVISION THE SURGEON DETERMINED THE FEMORAL COMPONENT WAS ALSO REVISED. THE SURGEON DID NOT COMMENT ON THE PATELLAR COMPONENT AND IT WAS NOT REVISED. THE PATIENT WAS IMPLANTED WITH DEPUY KNEE SYSTEM AND DEPUY BONE CEMENT. THERE WERE NO COMPLICATIONS REPORTED. DOI: (B)(6) 2016; DOR: (B)(6) 2017; (LT KNEE).

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 9317204 ↗
• InjuryJun 24, 2019Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE TIBIA DEBONDED FROM CEMENT UPON EXTRACTION WITH A MORELAND EXTRACTOR AND MALLET. FEMUR WAS WELL FIXED. INSERT HAD VISIBLE WEAR ON THE POSTERIOR ASPECT BOTH MEDIALLY AND LATERALLY. PATELLA REMAINS IN SITU. THE SURGEON WILL DISCUSS INTRAOPERATIVE FINDINGS WITH THE INVESTIGATOR. DOI: (B)(6) 2017; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8726804 ↗
• InjuryApr 12, 2018Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS PATELLA TRACKING COMPLICATION. IT WAS ALSO INDICATED THAT THE SURGEON ASSESSED THAT THE FEMORAL COMPONENT ROTATION WAS CORRECT AND DETERMINED THE TIBIAL COMPONENT ROTATION WAS CAUSING THE PATELLA TRACKING COMPLICATION. THE DECISION WAS MADE TO REMOVE THE TIBIAL COMPONENT AND REPLACE WITH A STEMMED ATTUNE TIBIAL COMPONENT. UPON REMOVING THE EXISTING TIBIA COMPONENT, THE SURGEON INSERTED AN OSTEOTOME TO THE ANTERIOR ASPECT OF THE COMPONENT AND HIT IT 2-3 TIMES WITH A MALLET. THE TIBIA COMPONENT DISLODGED IMMEDIATELY. BASED ON THE EASE OF REMOVAL, THE DOCTOR WAS CONCERNED ABOUT THE ATTUNE TIBIA'S LACK OF FIXATION TO THE CEMENT MANTLE IN LIGHT OF RECENT REPORTS QUESTIONING THIS VERY MATTER. IT IS IMPORTANT TO NOTE THAT THE TIBIA WAS NOT LOOSE NOR WAS THIS REVISION FOR A LOOSE TIBIA. IT WAS JUST CONCERNING TO DR. WADE THAT THE TIBIA CAME OUT SO EASILY AND HAD NO CEMENT MANTLE ATTACHED TO IT. DOI- (B)(6) 2016. DOR-(B)(6) 2017, UNKNOWN AFFECTED SIDE.

  Patient problems: No Information

  MAUDE report 7424581 ↗
• InjuryNov 6, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. POLY DISLOCATED TO POSTERIOR ASPECT OF THE KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 7002993 ↗