ATTUNE 1506-60-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295042860), received between Sep 23, 2021 and Sep 19, 2025 — classified as 8 injuries, 1 malfunction.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DRAINAGE SUGGESTING HE WAS STILL INFECTED. ALL WELL FIXED, WELL ALIGNED COMPONENTS WERE REMOVED. A THOROUGH DEBRIDEMENT WAS PERFORMED. BONE WAS THEN PREPARED FOR NEW IMPLANTS WHICH ARE PLACED WITH HIGH DOSE ANTIBIOTIC CEMENT ALONG WITH RESORBABLE BEADS THAT CONTAINED BOTH ANTIFUNGAL AND ANTIBIOTICS. NO DELAY WAS NOTED. PREVIOUS CEMENT WAS DEPUY 2 WITH GENT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 23099807 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ORIGINALLY OPERATED ON FOR AN INFECTED NON-UNION OF FUSION. SINCE CULTURES WERE NEGATIVE, SURGEON CHOSE TO REIMPLANT THE PATIENT. CONTINUED DRAINAGE SUGGESTS INFECTION. SINCE THE PATIENT CONTINUES TO DRAIN DESPITE NEGATIVE CULTURES, THE SURGEON CHOSE TO REMOVE ALL COMPONENTS AND CONVERT TO A STATIC SPACER UTILIZING LPS COMPONENTS, PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS AND HIGH DOSE ANTIBIOTIC CEMENT TO COAT THE COMPONENTS. ALL COMPONENTS WERE WELL FIXED BUT LACK OF BONY INGROWTH ALSO SUGGESTS PERSISTENT INFECTION. AND I&D WAS PERFORMED ON (B)(6) 2025, WHERE THE POLY AND PIN WERE REPLACED. DEPUY 2 WITH GENTAMICIN WAS LIKELY UTILIZED, AS THAT IS THE SURGEON'S NORM. NO DELAY OCCURRED AND NO PATIENT HARM WAS NOTED. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22214727 ↗
• InjuryDec 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND FRACTURED TIBIA. THE TIBIA IMPLANTS WERE EXPLANTED, AND NEW ONES WERE INSERTED WITH A LONGER STEM TO BYPASS THE FRACTURE. THERE WAS NO SURGICAL DELAY OR CONSEQUENCES TO THE PATIENT. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 21018809 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED, FOR RIGHT KNEE MOBILIZATION: DEVICE (RELATEDNESS): POSSIBLY. PROCEDURE (RELATEDNESS): PROBABLY. DATE OF EVENT: (B)(6) 2024. DATE OF REVISION: NO REVISION. DATE OF IMPLANT: (B)(6) 2024. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: HOSPITALIZATION/CLOSED REDUCTION/MANIPULATION.

  Patient problems: Insufficient Information

  MAUDE report 20693254 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE MOBILIZATION IS THIS EVENT RELATED TO THE STUDY DEVICE? POSSIBLY IS THIS EVENT RELATED TO THE STUDY PROCEDURE? PROBABLY. DEVICE LOCATION: RIGHT. DATE OF EVENT: 05 SEP 2024. DATE OF IMPLANT: (B)(6) 2024. TREATMENT/IMPACT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 20278260 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM DEPUY SYNTHES JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRIMARY SURGERY WAS PERFORMED WITH THE IMPLANTS IN QUESTION. AFTER THE SURGERY, THE PATIENT FELL AND HAD A PERIPROSTHETIC FEMORAL IMPLANT FRACTURE. THE REVISION SURGERY IS SCHEDULED ON AN UNKNOWN DATE TO FIX THE AFFECTED AREA WITH PLATE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Fall

  MAUDE report 17574686 ↗
• InjuryOct 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE INSERTED ON 2 DIFFERENT DATES AS A PARTIAL REVISION WAS PERFORMED ON THE SECOND DATE, (B)(6) 21. A DER WAS SUBMITTED AT THAT TIME. FIRST 3 ITEMS LISTED WERE LEFT FROM (B)(6) 2020 PROCEDURE, THE REST WERE PLACED IN (B)(6) 2021. PATIENT COMPLAINED OF TIBIAL PAIN. XRAYS APPEARED TO HAVE LUCENCIES ON THE TIBIAL SIDE SO A TIBIAL SIDE REVISION WAS PLANNED. INSERT AND FEMORAL COMPONENT WERE REMOVED FOR EXPOSURE, THEN TIBIAL TRAY AND STEM WERE REMOVED, BUT THE TIBIAL SLEEVE WAS FOUND TO BE WELL FIXED. THE SURGEON WANTED TO SHORTEN THE ADAPTER ON THE FEMORAL SLEEVE AND WHEN TRYING TO REMOVE THE ADAPTER THE FEMORAL SLEEVE AND STEM WERE EXTRACTED. AT THIS POINT, A TIBIAL AND FEMORAL REVISION WERE PERFUMED UNEVENTFULLY. THERE WAS NO PATIENT HARM. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 15526019 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REMAINS INFECTED. ALL COMPONENTS WERE REMOVED AND A SPACER WAS FASHIONED UTILIZING LPS COMPONENTS. CEMENT WAS DEPUY 2 WITH GENT BUT NO QUANTITY OR LOT INFORMATION IS AVAILABLE AS IT IS HOSPITAL OWNED INVENTORY. IT WAS ALSO REPORTED THAT TIBIAL AND FEMORAL COMPONENTS WERE LOOSE AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14207955 ↗
• MalfunctionSep 23, 2021Off-Label Use; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping; Off-Label Use; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE INFECTION AFTER THE FIRST SURGERY. THIS PC REPORTS ABOUT THE TRACES OF DIRT ON THE SURFACE OF THE TRAY USED IN THE REVISION SURGERY. ON (B)(6) 2021, THE PATIENT UNDERWENT THE REVISION SURGERY VIA TKA DUE TO INFECTION. THE TRAY IN QUESTION WAS PREPARED FOR THE REVISION SURGERY. IN THE REVISION SURGERY, IT WAS FOUND THAT THERE WERE TRACES OF DIRT ON THE SURFACE OF THE TRAY. THE SURGEON WIPED THE TRAY WITH A GAUGE, AND IT WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE SALES REP RECOMMENDED TO USE ANOTHER NEW TRAY, BUT THE SURGEON SAID THAT THERE IS NO TRAY WITHOUT TRACES OF DIRT OR A PROTECTIVE COVER ON THE J&J PRODUCT. AND THE SURGEON USED THE DIRTY TRAY AS IT WAS.

  Patient problems: Insufficient Information

  MAUDE report 12519572 ↗