ATTUNE 1516-50-805Recalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 10603295052845), received between Aug 28, 2017 and Jun 3, 2026 — classified as 98 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 99 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH SECOND LINER EXCHANGE TO RULE OUT INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25381340 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I&D POLY SWAP FOR SUSPECTED INFECTION. NO WAY TO CONFIRM INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25333670 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VOLUNTARY REPORT WAS RECEIVED (MW5185021). IT WAS REPORTED A 55-YEAR-OLD MALE PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT PAIN AND INSTABILITY OF THE JOINT SECONDARY TO LOOSENING OF THE TIBIAL TRAY, AS IDENTIFIED VIA PREOPERATIVE RADIOGRAPHS. UPON ENTERING THE JOINT, THE SURGEON CONFIRMED THE JOINT INSTABILITY AND DEBRIDED SCAR TISSUE. THE TIBIAL TRAT WAS GROSSLY LOOSE AT AN UNKNOWN INTERFACE AND REVISED. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATELLA WAS WELL-FIXED BUT RETAINED. THE PATIENT RECEIVED A COMPETITOR REVISION CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: ON (B)(6) 2023, DOR: ON (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Adhesion(s); Joint Laxity; Pain

  MAUDE report 25034110 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS UNSTABLE. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25033452 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH LAX KNEE POST OP TKR REQUIRING INSERT EXCHANGE. DOI-(B)(6) 2023, DOR-(B)(6)2026, AFFECTED SIDE-RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24765556 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FALL ON THE KNEE POST-OPERATIVELY, RESULTING IN AN INCISION OPENING AND NECESSITATING AN INCISION AND DRAINAGE (I&D) WITH A POLY SWAP. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall

  MAUDE report 24706687 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN AND LACKED FULL EXTENSION. ALL IMPLANTS WERE WELL FIXED. IN THIS SURGERY ADDITIONAL DISTAL FEMUR BONE WAS REMOVED. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 24690832 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF A TOTAL KNEE ARTHROPLASTY DUE TO GLOBAL INSTABILITY, WHERE THE ORIGINAL RPPS 8X5 POLY INSERT WAS REPLACED WITH AN 8X10 INSERT. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24271291 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION OR REPLACEMENT SURGERY DUE TO KNEE INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24202415 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR SEPTIC WASHOUT. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22915855 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN INITIAL SURGERY VIA TKA ON RIGHT KNEE WITH THE PRODUCT IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, ON (B)(6) 2025, THE PATIENT HAD A POSTOPERATIVE INFECTION AND WOULD NEED TO HAVE THE INSERT REPLACED OR THE IMPLANT REMOVED. ACCORDING TO THE SURGEON, SIGNS OF INFECTION WERE OBSERVED ON (B)(6) 2025. IN THE REVISION SURGERY, ON (B)(6) 2025, THE INSERT WAS REPLACED, AND THE AFFECTED AREA WAS CLEANED AND IRRIGATED. POSTOPERATIVE PROGRESS WILL BE MONITORED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 22906913 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE INFECTION. SURGEON DECIDED TO TAKE OUT THE IMPLANTS AND REPLACE WITH A CEMENT SPACER. NO ISSUES WERE REPORTED WITH IMPLANTS. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22890525 ↗
• InjuryAug 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING TIGHTNESS IN FLEXION BUT HAPPY WITH EXTENSION, SO DOCTOR SWAPPED POLY WITH THE SAME SIZE AFTER STRIPPING THE CAPSULE POSTERIORLY. THE PREVIOUS INSERT WAS DAMAGED UPON EXTRACTION BUT ALL PIECES WERE REMOVED AND THERE WAS NO HARM DONE TO THE PATIENT. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 22731189 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY WAS CHANGED DUE TO PATIENT FALLING AND OPENING THEIR WOUND. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 22716430 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21856940 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO MASSIVE JOINT EFFUSION. THERE WAS A POSSIBLE LOOSE TIBIA. LOOSENING INTERFACE IS CEMENT/IMPLANT. THE CEMENT MANUFACTURER IS UNKNOWN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Swelling/ Edema

  MAUDE report 21853740 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 21666839 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AND UNDERWENT POLY EXCHANGE AND SOFT TISSUE RELEASE DUE TO STIFFNESS. SURGICAL DELAY WAS UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity; Unspecified Tissue Injury

  MAUDE report 21592429 ↗
• InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF TIBIA AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURE WAS DEPUY. THERE WAS ALSO INFECTION IN KNEE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21514510 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON DETERMINED THAT THE PATIENT'S KNEE WAS NOT WELL BALANCED AND ELECTED TO DO TIBIA-ONLY REVISION. PRIMARY TIBIA AND INSERT WERE REMOVED AND REVISION TIBIA IMPLANTED. THERE WERE NO COMPLAINTS AND NO SURGICAL DELAYS. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21403281 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO A SEPTIC BACK, AND INFECTION SPREAD TO PATIENT'S KNEE. SURGEON PERFORMED WASHING OUT. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2016. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21377605 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO RECURRENT EFFUSION. SURGEON WASHED OUT A KNEE TO TAKE OUT THE IMPLANTED SPACER AND REPLACE IT WITH A NEW ONE. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Swelling/ Edema

  MAUDE report 21144260 ↗
• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. POLY WAS EXCHANGED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 20924524 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE PATIENT WAS REVISED, DUE TO LATERAL KNEE PAIN. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 20794872 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 20462453 ↗