LPS 1987-07-025Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10603295078517), received between Jul 21, 2017 and Sep 23, 2026 — classified as 52 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 52 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 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 50872021 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to fracture.DOI: Unknown,DOR: (b)(6), 2026,Affected side: Left Knee.

  Patient problems: Bone Fracture(s)

  MAUDE report 50543996 ↗
• 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 50129660 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to pain.DOI: UnknownDOR: 07-06-2026Affected Side: Right

  Patient problems: Pain

  MAUDE report 50045654 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to pain.DOI: Unknown,DOR: on (b)(6) 2026,Affected Side: Right.

  Patient problems: Pain

  MAUDE report 50045610 ↗
• 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 ON (B)(6) 2026 (B)(4), ON (B)(6) 2026 (B)(4), ON (B)(6) 2026 (B)(4). DOI: ON (B)(6) 2026, DOR: ON (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 25192849 ↗
• 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 24834925 ↗
• 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 23477221 ↗
• 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 23099871 ↗
• 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 22748409 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. PARTS WERE REPLACED TO REDUCE BIOBURDEN. DOI: UNKNOWN, DOR: (B)(6) 2025 , AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22649927 ↗
• 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 22441269 ↗
• 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) IS RELATED TO (B)(4). DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 22329684 ↗
• 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 22160344 ↗
• InjuryFeb 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 HAVE RECURRENT INFECTIONS AND INFLAMMATION AROUND PATIENT'S PROSTHESIS EVEN AFTER MULTIPLE 2 STAGE REVISIONS. THE QUESTION HAS BEEN RAISED AS TO WHETHER PATIENT IS HAVING A REACTION TO THE METAL. THEREFORE ALLERGY TESTING IS GETTING DONE FOR PATIENT BUT FOR THAT PATIENT NEEDS TO KNOW THE EXACT COMPOSITION OF IMPLANTS SO DERMATOLOGY KNOW WHAT TO TEST FOR.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 21314287 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A DISLOCATED DISTAL FEMUR REPLACEMENT AND WAS BROUGHT IN FOR REVISION. A 25 MM IPS SEGMENT AND A 26MM XSMALL LPS HINGE INSERT WERE REMOVED. A NEW 40MM LPS SEGMENT AND 23MM IPS SEGMENT WERE IMPLANTED. DOI: UNKNOWN. DOR:(B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 19939167 ↗
• InjuryMay 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: Joint Laxity

  MAUDE report 19437426 ↗
• InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED, DUE TO INFECTED LEFT TOTAL KNEE. IMPLANTED DFR ON (B)(6) 2023. AND A POLY EXCHANGE ON (B)(6) 2023. PATIENT CAME INFECTED, SO THEY EXPLANTED ALL IMPLANTS AND IMPLANTED A CEMENT SPACER USING ANTIBIOTIC SPACER AND EX-FIX RODS AND CONNECTOR. DOI: (B)(6) 2023, DOR: (B)(6) 2024. AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 18776680 ↗
• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. PLEASE CONFIRM WAS THE INFECTION CLEARED. UNKNOWN. LITTLE TO NO WAY TO CONFIRM OR RULE OUT INFECTION DURING A PROCEDURE. TISSUES LOOKED GOOD AT THE TIME OF SURGERY, HOWEVER, DUE TO PREVIOUS CONFIRMED INFECTION, IT WAS TREATED AS IF STILL INFECTED. B. WAS THE STEM LOOSE AS WELL? WHICH SLEEVE WAS LOOSE? -FEMORAL STEM WAS ALSO LOOSE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 18517694 ↗
• InjuryDec 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS COMPLAINING ON THIGH PAIN, SURGEON WAS WORRIED ABOUT LACK OF BONE GROWTH WITHIN THE FEMORAL STEM PROSTHESIS. UPON INSPECTION, THE ENTIRE PROSTHESIS WAS REMOVED FROM THE FEMORAL SIDE AND A CEMENTED BOWED STEM WAS IMPLANTED. A LARGER INSERT WAS ALSO TRAILED AND THEN INSERTED. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 18392962 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH AN INFECTED JOINT REPLACEMENT. AN IRRIGATION AND DEBRIDEMENT (I&D) WAS PERFORMED WITH PLANNED EXCHANGE OF MODULAR COMPONENTS AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. STEM WAS IMPLANTED ON (B)(6) 2023. FEMUR SEGMENT AND INSERT WERE EXCHANGED ON (B)(6) 2023 POST FALL AND DEHISCENCE OF INCISION. NO PATIENT HARM OCCURRED. NO DELAY WAS EXPERIENCED. IN AN EFFORT TO REMOVE THE SEGMENT OF AN DISTAL FEMUR, THE CEMENTED STEM WAS ALSO REMOVED. NEW COMPONENTS WERE IMPLANTED UNEVENTFULLY. DOI: (B)(6) 2023; DOI(STEM): (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18132343 ↗
• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IRRIGATION AND DEBRIDEMENT DONE FOR INFECTION WITH REPLACEMENT OF MODULAR COMPONENTS. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18088448 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION, WASH OUT AND SWAPPED COMPONENTS. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17952668 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE STEM AND ATTUNE FEMORAL SLEEVE AT THE BONE TO IMPLANT INTERFACE. PATIENT CAME IN TO ER WITH DISLOCATED DEPUY LPS DISTAL FEMORAL REPLACEMENT. WHILE OPENING TO REVISE, IT WAS ALSO APPARENT THAT THE KNEE WAS INFECTED. ALL IMPLANTS WERE REMOVED EXCEPT THE TIBIA BASEPLATE, TIBIAL SLEEVE AND STEM. ANTIBIOTIC SPACER IMPLANTED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17948330 ↗
• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17226225 ↗