ATTUNE LPS 1517-60-118Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295491095), received between Sep 1, 2023 and Sep 19, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 15, 2023Class IIOpen, Classified

   The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.

   Z-1263-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗

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 23099803 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ASPIRATED LAST WEEK AND IS NOW GROWING YEAST. ALL COMPONENTS WERE REMOVED IN A ONE STAGE REVISION AND NEW COMPONENTS WERE PLACED AFTER A THOROUGH I&D AND PLACEMENT OF RESORBABLE BEADS CONTAINING ANTIBIOTICS AND AN ANTIFUNGAL AGENT. ALL COMPONENTS WERE FUNCTIONING AS EXPECTED HOWEVER THE FEMORAL SLEEVE HAD FAILED TO INGROW, LIKELY DUE TO THE FUNGUS BEING PRESENT. TIBIAL COMPONENT AND CEMENTED STEM WERE PLACED ON THE ABOVE LISTED DATE. FEMORAL COMPONENTS AND INSERT HAD BEEN REVISED ON (B)(6) 2025 FOR CONTINUED INFECTION. A DER WAS FILED UNDER (B)(4) PER OPTIMIZE. DOI: (B)(6)2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22748464 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAINED OF MOBILITY. DOI: (B)(6), 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 22293789 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUES TO SHOW SIGNS OF INFECTION AND WAS BROUGHT TO THE OR FOR BILATERAL KNEE REVISIONS. COMPONENTS WERE REMOVED AND THOROUGH I&DS WERE PERFORMED IN CONJUNCTION WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS, AND PLACEMENT OF NEW COMPONENTS. PATIENT DID HAVE BILATERAL I&DS WITH POLY EXCHANGES ON (B)(6) 2025. AS SUCH, THE INSERTS LISTED ON THIS SUBMISSION WERE FROM THAT DATE. THE RIGHT KNEE SHOWED SIGNIFICANT HETEROTOPIC OSSIFICATION AROUND THE FEMORAL SLEEVE, SUGGESTING INFECTION ON XRAY, SO SURGEON TO CHOSE TO FASHION A STATIC SPACER UTILIZING LPS COMPONENTS TO TREAT THIS SIDE. THE LEFT SIDE APPEARED TO BE DOING BETTER, BUT SINCE HOSPITAL ADMISSION EARLIER THIS WEEK ALSO BEGIN TO SWELL. WHEN CHECKING FIXATION OF THE FEMORAL COMPONENT, THE FEMORAL SLEEVE WAS ABLE TO BE REMOVED WITHOUT SIGNS OF BONY INGROWTH. LACK OF INGROWTH APPROXIMATELY SEVEN (7) WEEKS POST IMPLANTATION SUGGESTS THIS TOO WAS INFECTED. TIBIAL COMPONENT AND STEM WERE LEFT IN PLACE ON THE LEFT SIDE SINCE IT WAS WELL FIXED. NO DELAY NOR PATIENT HARM WAS NOTED. WHILE RESULTS ARE NOT YET AVAILABLE, SURGEON DOES BELIEVE INFECTION WAS STILL PRESENT AT THE TIME OF THIS PROCEDURE. THIS INFEC

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 22160371 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. PATIENT CONTINUES TO DRAIN AFTER BILATERAL REVISION TKAS FOR INFECTION. CULTURES FROM PREVIOUS CASES ALL SHOW THE SAME SENSITIVE ORGANISM BUT DRAINAGE CONTINUES TO OCCUR EVEN WITH COMPLETE IMPLANT EXCHANGE . A THOROUGH I&D WITH POLY EXCHANGES WERE PERFORMED ON BOTH SIDES WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS WITHOUT SURGICAL DELAY OR PATIENT HARM. CULTURES WERE TAKEN ON BOTH SIDES INTRAOPERATIVELY. DOI: UNKNOWN DOR: UNKNOWN AFFECTED SIDE: LEFT KNEE. THIS REPORT CAPTURES THE LEFT KNEE. THE RIGHT KNEE IS CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 21995853 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED BECAUSE OF PATELLAR TRACKING ISSUES. SURGEON SWITCHED OUT THE EXTRA SMALL 18 MM LPS POLY TO A 22 MM EXTRA SMALL LPS POLY AND DID A LATERAL RELEASE TO IMPROVE PATELLAR TRACKING. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21953906 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED KNEE, POLY EXCHANGE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18172957 ↗
• InjurySep 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT FELL AND SUSTAINED A SOFT TISSUE INJURY AFTER THE FIRST SURGERY AND DFR. DURING THIS FALL, SURGEON SUSPECTS THAT THE PREVIOUSLY SUTURED SOFT TISSUE ENVELOPE BECAME BROKEN CAUSING THE PATELLA TO BECOME DISLOCATED LATERALLY. BY THE TIME THE SURGERY WAS SCHEDULED, THE PATELLA TENDON AND ALL THE SOFT TISSUES WERE SCARRED DOWN AND MADE THE PATELLA TRACK LATERALLY AND INHIBITED THEIR RANGE OF MOTION. IN ORDER TO HELP WITH THIS, THE SURGEON DECIDED TO REMOVE THE DISTAL FEMORAL COMPONENT IN ORDER TO EXTERNALLY ROTATE THE FEMUR AND HELP WITH THE LIMITED PATELLA FUNCTION AND OVERALL RANGE OF MOTION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Fall; Joint Dislocation; Joint Laxity; Loss of Range of Motion; Unspecified Tissue Injury

  MAUDE report 17818573 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FALL. THE FALL CREATED A TEAR ON HER QUADRICEPS MECHANISM. SURGEON CHOSE TO REDUCE INSERT THICKNESS TO REDUCE TENSION ON THE REPAIR. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 17669395 ↗