ATTUNE LPS 1517-60-112Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 10603295491064), received between Nov 24, 2020 and Sep 30, 2026 — classified as 68 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 25 most recent of 68 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Device Dislodged or Dislocated

  Patient problems: Joint Dislocation

  MAUDE report 50951792 ↗
• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient presents post revision TKA after a static spacer had been utilized to treat infection. She has signs of possible infection to include drainage and wound breakdown. A thorough I&D is performed and components are then exchanged with placement of resorbable antibiotic beads. No delay nor patient harm is noted. No allegation is made against any components.DOI- (b)(6) 2026,DOR- (b)(6) 2026,Affected side- Left knee.

  Patient problems: Unspecified Infection

  MAUDE report 50436874 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the infection was confirmed. They performed washout & Liner exchange.Affected side: Right side.

  Patient problems: Unspecified Infection

  MAUDE report 50054024 ↗
• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL TRAY, SLEEVE, AND STEM AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION POST REVISION TKA. ALL COMPONENTS WERE REMOVED AND A STATIC SPACER WAS PLACED UTILIZING LPS COMPONENTS WITH HIGH DOSE ANTIBIOTICS AND RESORBABLE ANTIBIOTIC BEADS. SIGNIFICANT BONE LOSS WAS NOTED ON THE TIBIA AS THE INFECTION APPEARED TO HAVE BEEN PRESENT FOR SOME TIME BUT WAS UNTREATED UNTIL PATIENT SHOWED UP IN THE ER. NO DELAY OR PATIENT HARM WAS NOTED. NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25503642 ↗
• 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 HIS PROSTHESES. 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 ON (B)(6) 2026 (B)(4), ON (B)(6) 2026 (B)(4), ON (B)(6) 2026 (B)(4) CEMENT THAT WAS USED WAS DEPUY 2 WITH GENT BUT IS HOSPITAL OWNED SO NO LOT INFORMATION IS AVAILABLE IN OUR RECORDS. DOI: ON (B)(6) 2026, DOR: ON (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 25192952 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT IS ADMITTED TO AN OUTSIDE FACILITY POST REV TKA FOR EXCESSIVE BLEEDING THROUGH THE DRESSING AND THE PATIENT WAS TRANSFERRED. PATIENT WAS SCHEDULED FOR AN I&D AND COMPONENT EXCHANGE. ALL COMPONENTS WERE WELL FIXED AND MODULAR WERE EXCHANGED DUE TO RISK OF INFECTION. NO ALLEGATION WAS MADE AGAINST ANY COMPONENT AND NO DELAY NOR PATIENT HARM WAS NOTED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25128325 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTS WITH DRAINING POST REVISION TKA THAT WAS TREATED WITH A STATIC SPACER FOR INFECTION. WHILE ASPIRATION PRIOR TO REIMPLANTATION WAS NEGATIVE FOR INFECTION, PATIENT NOW WAS POSITIVE FOR A FUNGAL INFECTION AND ALL COMPONENTS WERE REMOVED AN A NEW STATIC SPACER WAS PLACED IN CONJUNCTION WITH RESORBABLE ANTIBIOTIC BEADS LOADED WITH ANTIBIOTIC AND ANTIFUNGAL MEDICATION. NO DELAY NOR PATIENT HARM WAS NOTED. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24834920 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A HEMATOMA POST REVISION TKA. SURGEON PERFORMED AN EVACUATION OF HEMATOMA WITH A THOROUGH I&D AND COMPONENT EXCHANGE. ALL COMPONENTS WERE WELL FUNCTIONING SO NO ALLEGATION WAS MADE AGAINST ANY COMPONENT, HOWEVER CHOSE TO EXCHANGE MODULAR COMPONENTS AS THE RISK FOR INFECTION IS ELEVATED IN THIS CIRCUMSTANCE. CABLE WAS ALSO REMOVED AS IT COULD HARBOR BACTERIA IF INFECTION IS FOUND TO BE PRESENT ON CULTURES. CULTURES WERE TAKEN AS A PRECAUTION AND RESORBABLE ANTIBIOTIC BEADS WERE PLACED. NO DELAY OR PATIENT HARM WAS NOTED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hematoma

  MAUDE report 24731147 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN LPS DISTAL FEMORAL REPLACEMENT REVISION TKA PLACED ON (B)(6) 2025. HE PRESENTED WITH A DRAINING KNEE AND WAS BROUGHT TO THE OR FOR A ONE STAGE REVISION UTILIZING A DUAL SET UP. ALL COMPONENTS WERE FUNCTIONING AS EXPECTED SO NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. CEMENT WAS DEPUY 2 WITH GENT, HOWEVER IS HOSPITAL OWNED SO NO QTY OR LOT INFORMATION IS AVAILABLE. BOTH TIBIAL AND PATELLAR COMPONENTS WERE WELL FIXED VIA CEMENT SO NO ALLEGATION IS MADE AGAINST THE CEMENT. WHILE WELL FIXED, NO INGROWTH WAS FOUND ON EITHER SLEEVE, FURTHER CONFIRMING INFECTION. A THOROUGH IRRIGATION AND DEBRIDEMENT WAS PERFORMED AFTER ALL COMPONENTS WERE REMOVED. NEW COMPONENTS WERE PREPARED FOR. NEW COMPONENTS WERE OPENED ON A "CLEAN" TABLE AND IMPLANTED AFTER NEW DRAPES AND STAFF CHANGING INTO "CLEAN" GOWNS AND GLOVES WAS COMPLETED. ALL NEW COMPONENTS WERE PLACED ALONG WITH RESORBABLE ANTIBIOTIC BEADS AND ANTIBIOTIC CEMENT. NO DELAY NOR PATIENT HARM WAS NOTED. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 24267236 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATUNE PRESSFIT STR STEM14X60MM, ATUN TIB SLV M/L 45MM FULL POR, ATUNE REV RP TIB BASE SZ 4 CEM, ATTUNE REV LPS INSRT XXSM 12MM, LPS DISTAL FEM COMP XXSM RT, ATT REV SLV LPS FEM ADP +5, ATUN FEM SLV M/L 45MM FULL POR, AND ATUN PRESSFIT STR STEM12X110MM WERE INVOLVED IN A REPORTED EVENT. THE PATIENT, WHO HAD PREVIOUSLY RECEIVED A REVISION KNEE POST SPACER FOR INFECTION, PRESENTED WITH WOUND DRAINAGE. ALL IMPLANTED COMPONENTS WERE REMOVED, AND THOROUGH DEBRIDEMENT AND IRRIGATION WERE PERFORMED. A NEW SPACER WAS FASHIONED USING LPS COMPONENTS, RESORBABLE ANTIBIOTIC BEADS, AND HIGH-DOSE ANTIBIOTIC CEMENT. NO DEVICE MALFUNCTION WAS ALLEGED, AND ALL COMPONENTS WERE REPORTED TO BE FUNCTIONING AS EXPECTED. THE TIBIAL COMPONENT WAS WELL FIXED, AND THE EVENT WAS ATTRIBUTED TO INFECTION RATHER THAN DEVICE FAILURE. ALL LISTED PRODUCTS WERE EXPLANTED DURING THE PROCEDURE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 24258290 ↗
• 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 23404457 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PROGRESSIVE LUCENT LINES AROUND COMPONENTS AND PAIN, SUGGESTING FAILED FIXATION. IMPLANTS WERE REMOVED UNEVENTFULLY AND REIMPLANTED WITH NEW COMPONENTS. FROZEN SECTION WAS NEGATIVE FOR INFECTION. CEMENT HAD NOT ADHERED TO THE BONE, BUT THE TIBIAL SLEEVE WAS WELL FIXED AND THUS LEFT IN PLACE. THE FEMORAL COMPONENTS HAD BEEN REVISED ON (B)(6) 2024 FOR FAILED INGROWTH AND A CEMENTED STEM WAS PLACED AT THAT TIME. POLY WAS REVISED (B)(6) 2024 WHEN EXCESSIVE SCAR TISSUE WAS REMOVED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 23380112 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT NOT LOOSE, JUST NOT INGROWN. NOT THE SAME THING.

  Patient problems: Unspecified Infection

  MAUDE report 22871757 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO I&D POLY SWAP. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22846116 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS INFECTION AND ALL COMPONENTS WERE REMOVED AND A SPACER WAS MADE WITH NEW COMPONENTS. HIGH DOSE ANTIBIOTICS WERE PLACED ON COMPONENTS ALONG WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. HICKMAN CATHETERS WERE ALSO PLACED TO PROVIDE ADDITION ANTIBIOTIC TREATMENT POSTOPERATIVELY. NO PATIENT HARM WAS NOTED AND NO DELAY OCCURRED. INITIAL PROCEDURE FEMORAL SIDE COMPONENTS WERE REVISED ON (B)(6) 2024. AN I&D WITH FEMUR AND INSERT EXCHANGE WAS PERFORMED ON (B)(6) 2025 AND DER (B)(4) WAS SUBMITTED. THERE WAS A LOOSENING REPORTED AT STEM ON BONE TO CEMENT INTERFACE. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22373467 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUED TO DRAIN FROM KNEE WOUND. SURGEON ELECTED TO REMOVE KNEE PROSTHESIS AND FUSE THE KNEE. THIS COMPLAINT (B)(4). DOI: UNKNOWN . DOR: (B)(6) 2025 . AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 22328579 ↗
• 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 22214722 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INSTABILITY. DOI: UNKNOWN. DOR:(B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22100118 ↗
• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTS WITH SUSPECTED INFECTION POST REVISION TKA. SURGEON PERFORMS A THOROUGH I&D WITH COMPONENT EXCHANGE WITHOUT DELAY OR PATIENT HARM TO INCLUDE PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. NO ALLEGATION IS MADE AGAINST ANY COMPONENT AS THEY ARE WELL FUNCTIONING. DOI: (B)(6) 2024, DOR:(B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22044886 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUES TO REMAIN INFECTED. SURGEON ELECTED TO REMOVE SOME COMPONENTS AND FUSE THE KNEE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22027148 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH POOR PATELLAR TRACKING AND WAS SCHEDULED FOR SURGERY TO ADDRESS. AFTER EXPOSURE, SURGEON NOTED THE FEMORAL COMPONENT APPEARED TO BE INTERNALLY ROTATED. WHILE EXTRACTING THE FEMORAL COMPONENT HE NOTICED THAT THE FEMORAL SLEEVE ALSO MOVED INDICATING THAT IT HAD NOT YET INGROWN. THIS LED THE SURGEON TO BELIEVE THAT THE PATIENT COULD STILL BE INFECTED AS HE WAS TREATED AT THE PREVIOUS SURGERY WITH A ONE STAGE REVISION FOR INFECTION. FROZEN SECTION WAS SENT TO PATHOLOGY AND SHOWED 5 WHITE CELLS/ HIGH POWERED FIELD. THIS RESULT WAS MORE INDICATIVE OF A LOOSE COMPONENT THAN INFECTION BUT SURGEON FELT COMPELLED TO PROCEED AS IF INFECTED AND ALSO SENT CULTURES. FEMORAL COMPONENTS WERE REMOVED AND A THOROUGH DEBRIDEMENT AND IRRIGATION WAS PERFORMED. FEMUR WAS THEN PREPARED FOR NEW COMPONENTS AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. NO DELAY WAS ENCOUNTERED AND NO PATIENT HARM NOTED. PATELLAR TRACKING AND MOTION WERE FOUND TO BE IMPROVED WITH NEW COMPONENTS IN PLACE. THERE WAS LOOSENING REPORTED AT NON CEMENTED INTERFACE AT FEMORAL SLEEVE. DOI: (B)(6), 2025 DOR: (B)(6) 2025 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 21952618 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A POST OPERATIVE HEMATOMA AFTER A COMPLEX PRIMARY KNEE REPLACEMENT UTILIZING REVISION COMPONENTS. ALL COMPONENTS WERE REMOVED AND EXCHANGED UNEVENTFULLY WITH NO PATIENT HARM NOR DELAY. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hematoma

  MAUDE report 21944665 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY EXCHANGE AND WASH OUT WAS PERFORMED. NO FURTHER DETAILS WERE PROVIDED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21935860 ↗
• InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REQUIRED LUP SURGERY FOR DISTAL FEMUR FOLLOWING SHOT GUN WOUND AND LPS WAS IMPLANTED. TWO WEEKS AFTER THE INITIAL SURGERY A DAIR WAS CARRIED OUT DUE TO THE PATIENT HAVING AN INFECTION IN THE JOINT AND CONTINUED TO ASPIRATE. THE PATIENT HAD POLY SWAP OUT.

  Patient problems: Unspecified Infection

  MAUDE report 21102537 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTS WERE REMOVED DUE TO INFECTION. A SPACER WAS PLACED UTILIZING LPS COMPONENTS IN A DUAL SET UP FASHION IN CONJUNCTION WITH A THOROUGH I&D WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. NO DELAY NOR PATIENT HARM TOOK PLACE. NO ALLEGATION WAS MADE AGAINST ANY COMPONENTS AT THIS TIME, AS ALL WERE WELL FIXED AND WELL FUNCTIONING. FEMORAL SIDE HAD BEEN REVISED ON (B)(6) 2023 AND AGAIN ON (B)(6) 2024. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20426341 ↗