ATTUNE 1511-06-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295503415), received between Aug 3, 2021 and Sep 23, 2026 — classified as 21 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Patients presents in the emergency room with pain. Exam suggests movement of the static spacer utilizing LPS components. In the operating room, there is movement between the taper from the femoral sleeve adapter and the LPS segment. Existing modular components were removed. Tapers were thoroughly cleaned and dried and new components were placed successfully with no delay nor patient harm. No visible damage was found.DOI-(b)(6) 2026.DOR-(b)(6) 2026.Affected side- Right.

  Patient problems: Pain

  MAUDE report 50872040 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Patients presents in the ER with pain. Exam suggests movement of the static spacer utilizing LPS components. In the OR, there is movement between the taper from the femoral sleeve adapter and the LPS segment. Existing modular components were removed. Tapers were thoroughly cleaned and dried and new components were placed successfully with no delay nor patient harm. No visible damage was found.DOI-(b)(6) 2026.DOR-(b)(6) 2026.Affected side-Right.

  Patient problems: Pain

  MAUDE report 50872007 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Fluid Discharge

  MAUDE report 50129663 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was draining and surgeon elected to wash out and change components.DOI: (b)(6)2026,DOR:(b)(6)2026,Affected Side: Right.

  Patient problems: Fluid Discharge

  MAUDE report 50129657 ↗
• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50116426 ↗
• InjuryJun 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS STILL INFECTED. THE IMPLANTS WERE REMOVED AND REPLACED WITH NEW COMPONENTS. DOI: UNKNOWN DOR: (B)(6) 2026 AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 25553755 ↗
• InjuryMay 18, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT PRESENTED IN THE ER WITH POOR FUNCTION AND PAIN. FEMORAL COMPONENT APPEARED TO HAVE ROTATED ROUGHLY 90 DEGREES INTERNALLY. THE STEM, SLEEVE AND LPS ADAPTER WERE PLACED INITIALLY AND LEFT IN PLACE WHEN CONVERTED FROM A SPACER TO A REV TKA USING AN IPS DISTAL FEMUR ON (B)(6) 2026. THERE APPEARED TO BE DAMAGE ON THE TAPER OF THE ADAPTER AND UNFORTUNATELY IT COULD NOT BE REMOVED. THE STEM, SLEEVE AND ADAPTER WERE ALL REMOVED AND NEW COMPONENTS WERE PLACED WITH NO DELAY NOR PATIENT HARM. DOIL (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 25205201 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD WOUND BREAKDOWN POST MULTIPLE REVISION TKA LEADING TO POTENTIAL CONTAMINATION OF THEIR PROSTHESES. THE SURGEON CHOSE TO REMOVAL ALL WELL FIXED AND WELL FUNCTIONING COMPONENTS AND PLACE A STATIC SPACER FASHIONED WITH LPS COMPONENTS WITHOUT DELAY NOR PATIENT HARM. A GASTROC FLAP WAS PERFORMED BY THE PLASTIC SURGEON POST SPACER PLACEMENT IN HOPES OF HEALING THIS WOUND. THIS PATIENT HAS HAD MULTIPLE SURGERIES SINCE THIS DATE TO ADDRESS COMPLICATIONS WITH IMPLANTS BEING EXCHANGED. THE DATES WERE AND THE DER NUMBERS ARE LISTED (B)(6) 2026 (B)(6) ,(B)(6) 2026 (B)(6) ,(B)(6) 2026, (B)(6). DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 25192667 ↗
• InjuryMar 25, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT PRESENT WITH AN LPS STATIC SPACER POST INFECTION THAT HAD DISASSOCIATED. THIS IS AN UNUSUAL OCCURRENCE AS SURGEON UTILIZES THESE COMPONENTS REGULARLY FOR THIS INDICATION. INFECTION HAS CLEARED AND SEGMENTS AND COMPONENTS ON TIBIAL SIDE WERE REMOVED TO PLACE AN LPS DISTAL FEMORAL REVISION TKA. ALL COMPONENTS WERE WELL FIXED. CEMENT UTILIZED FOR THE SPACER WAS HOSPITAL OWNED SO NO LOT NOR QUANTITY INFORMATION IS AVAILABLE IN OUT RECORDS. NO DELAY NOR PATIENT HARM WAS NOTED. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE-RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691099 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT PRESENTS WITH INFECTION POST SPACER. HOWEVER, PATIENT NOW PRESENTS WITH A FUNGAL INFECTION. ALL COMPONENTS PERFORMED AS EXPECTED AND WERE WELL FIXED, HOWEVER HAD TO BE REMOVED TO TREAT THIS NEW FINDING. ALL COMPONENTS WERE SUCCESSFULLY REMOVED, AND AFTER A THOROUGH DEBRIDEMENT, THE BONE WAS PREPARED FOR NEW COMPONENTS. DURING DEBRIDEMENT, A VESSEL WAS PERFORATED DUE TO SCAR TISSUE AND WAS REPAIRED OPERATIVELY. THE SURGEON STATED THIS TO BE A COMMON OCCURRENCE DUE TO THE LOCATION OF DEBRIDEMENT ANATOMICALLY AND WAS EXPECTED AND PREPARED FOR. THIS RESULTED IN A SHORT DELAY WHILE THE REPAIR TOOK PLACE. NEW COMPONENTS WERE PLACED UNEVENTFULLY FOR A NEW SPACER, ALONG WITH PLACEMENT OF ANTIBIOTIC BEADS, ANTIFUNGAL BEADS AND HIGH DOSE ANTIBIOTIC CEMENT. DOI: (B)(6) 2025. DOR: (B)(6) 2026.

  Patient problems: Adhesion(s); Hemorrhage/Blood Loss/Bleeding; Unspecified Infection

  MAUDE report 24164640 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD STATIC SPACER PLACED DUE TO INFECTION. INFECTION CLEARED VIA ASPIRATION. PATIENT CONVERTED TO DISTAL FEMORAL REPLACEMENT UNEVENTFULLY. THERE WAS NO PATIENT HARM AND NO DELAY NOTED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23730116 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CONTINUES TO BE INFECTED. THE SPACER AND ALL CEMENT ARE REMOVED. A THOROUGH I&D IS PERFORMED AND A NEW SPACER IS FASHIONED UTILIZING LPS COMPONENTS. NO PATIENT HARM NOR DELAY WAS NOTED. DOI: (B)(6) 2025. DOR: (B)(6) 2025 . AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23477233 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE EXTRACTED DUE TO INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23404456 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUES TO DRAIN AFTER HER PROCEDURE. LABS LOOK GOOD AND ASPIRATION IS NEGATIVE FOR INFECTION. SURGEON BELIEVES THE ANTIBIOTICS PLACED A THE TIME OF SURGERY ARE CAUSING THE DRAINAGE, SO HE CHOSE TO REMOVE ALL COMPONENTS AND PLACE NEW ONES. NO DELAY NOR PATIENT HARM IS NOTED. NO ALLEGATIONS WERE MADE AGAINST ANY COMPONENT AS THEY WERE FUNCTIONING AS EXPECTED. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Fluid Discharge

  MAUDE report 22441288 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD KNEE REVISION ON A DISTAL FEMUR DUE TO PATELLA INSTABILITY. PATELLA WAS NATURAL AND WAS NOT RESURFACED OR REVISED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22071124 ↗
• InjuryFeb 19, 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 PAIN. THE SURGICAL DELAY IS UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21410033 ↗
• InjuryMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CONTINUES TO BE INFECTED. SURGEON PERFORMS A THOROUGH I&D AND MODULAR COMPONENT EXCHANGE IN HOPES TO CLEAR UP. NO PATIENT HARM OCCURRED NOR DELAY WAS EXPERIENCED. NO LOT INFORMATION WAS AVAILABLE DUE TO TRANSITION TO OPTIMIZE. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19239063 ↗
• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: NO DELAY.

  Patient problems: Pain

  MAUDE report 18806449 ↗
• InjuryJul 25, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT PRESENT IN OFFICE WITH THIGH PAIN. SERIAL X-RAYS SHOW LUCENCY AROUND STEM AND SUBSIDENCE OF SLEEVE LEADING SURGEON TO BELIEVE THAT THE STEM SLEEVE DID NOT ACHIEVE STABLE INGROWTH. SLEEVE IS FOUND TO HAVE ONLY ACHIEVED FIBROUS INGROWTH AND IS REMOVED. A CEMENTED BOWED STEM IS PLACED UNEVENTFULLY AFTER CLEARING FIBROUS TISSUE. NO PATIENT HARM OCCURRED. NO SURGICAL DELAY. DOI: (B)(6), 2022. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 17391107 ↗
• InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO THE INFECTION. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14218698 ↗
• InjuryAug 3, 2021Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS BEING TREATED FOR INFECTION. SO, WHETHER THE INFECTION HAD CLEARED SINCE THE DATE OF SURGERY WOULD BE UNLIKELY. HOWEVER, THIS WAS NOT A NEW INFECTION, IT WAS A RECURRENT INFECTION THAT HAS BEEN BEING TREATED FOR YEARS. THE REASON FOR EXCHANGING THE COMPONENTS WAS CONTAMINATION DUE TO THE IMPLANT PERFORATING HIS SKIN.

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

  MAUDE report 12270438 ↗