ATTUNE 1516-30-708Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295048015), received between Nov 21, 2017 and Feb 24, 2026 — classified as 10 injuries.

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

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SPACER WAS EXPLANTED FOR INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24426780 ↗
• InjuryMar 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) 2022. DATE OF REVISION: (B)(6) 2023. (LEFT KNEE). TREATMENT: REVISION; INSERT WAS REVISED.

  Patient problems: Joint Laxity

  MAUDE report 16598315 ↗
• InjuryJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI- (B)(6) 2022. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16239557 ↗
• InjuryJul 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. THE SURGEON OPENED THE CAPSULE, REMOVED THE POLY INSERT, WASHED OUT THE JOINT WITH COPIOUS AMOUNTS OF SALINE SOLUTION AND BATHED THE JOINT WITH A DILUTED BETADINE WASH AND IMPLANTED A NEW DEPUY PRODUCTS. THE SURGEON THEN IRRIGATED WITH IRRISEPT AND CLOSED THE WOUND. TO RECAP: LEFT KNEE ONLY WAS AFFECTED (INFECTED). ONLY ONE IMPLANT (POLY INSERT) WAS REPLACED. CASE WAS NOT DELAYED IN ANY WAY. THE SURGEON SENT THE JOINT FLUID SPECIMENS TO THE LAB BUT RESULTS WERE NOT AVAILABLE AT CLOSING. NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 12219584 ↗
• InjuryJan 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. DATE OF IMPLANT: (B)(6) 2020, DATE OF EVENT: (B)(6) 2020, DATE OF REVISION: (B)(6) 2021, (RIGHT KNEE). REVISION OF FEMORAL, TIBIAL AND INSERT COMPONENTS. FEMORAL COMPONENT: PRODUCT: 150401207, LOT: 9287085. INSERT COMPONENT: PRODUCT: 151630708, LOT: 9263016. TIBIAL COMPONENT: PRODUCT: 150611006, LOT: 9141123.

  Patient problems: Joint Laxity

  MAUDE report 11213039 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF AN ATTUNE PRIMARY (IMPLANTED ON (B)(6) 2020) DUE TO INFECTION.

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

  MAUDE report 10894909 ↗
• InjuryOct 12, 2020Naturally Worn; Naturally Worn

  REVISION OF LEFT ATTUNE CR RP PRIMARY KNEE, WITH DATE OF PRIMARY SURGERY (B)(6) 2017. ORIGINAL IMPLANTS WERE SIZE 7 LEFT CR FEMUR, SIZE 7 RP TIBIAL BASEPLATE, SIZE 7, 8MM CR RP INSERT, NO PATELLA RESURFACING AT INDEX PROCEDURE. CMWII IN SEPARATE MIXES FOR TIBIA AND FEMUR HAD BEEN USED. PATIENT XRAYS LOOKED FINE POST OP, AT 6 MONTHS SHOWED SOME RLL, THEN AT 2.5 YEARS PATIENT STARTED TO FEEL SEVERE PAIN IN BOTH SIDES, AND XRAYS SHOWED LOOSENING ON BOTH FEMURS QUERY OF SOME CYSTS ON TIBIA ALSO. LEFT SIDE WAS MOST PAINFUL, SO WAS FIRST TO BE REVISED. FEMUR CAME OFF VERY EASILY, WITH FIBROUS MEMBRANE SURROUNDING THE BONE, AND CYSTS AROUND THE FEMORAL LUG HOLES. TIBIA WAS MORE WELL FIXED, BUT THE CR RP POLY HAD SEVERE WEAR WITH LOTS OF PITTING ALL OVER THE ARTICULATING SURFACE AND SIGNS OF BACKSIDE WEAR UNDERNEATH. TIBIAL TRAY WAS LOOSE, BUT NOT AS LOOSE AS THE FEMUR. NO SIGNS OF ANY LOOSE BODIES IN THE JOINT. NO CONFIRMED INFECTION.

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

  MAUDE report 10662391 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN, DISCOMFORT, DECREASED RANGE OF MOTION, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE FEMORAL AND PATELLAR COMPONENTS WERE WELL-FIXED AND RETAINED. COMPETITOR CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2016; DOR: (B)(6) 2019; LEFT KNEE.

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

  MAUDE report 9707664 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INSTABILITY AND LOOSE TIBIAL COMPONENT.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 9503544 ↗
• InjuryNov 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS CONFIRMED INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7048396 ↗