LPS 1987-09-055Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295078616), received between May 12, 2020 and Aug 4, 2026 — classified as 20 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• 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 50129661 ↗
• InjuryJun 19, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 25562516 ↗
• InjuryMar 25, 2026Device Dislodged or Dislocated

  IT WAS REPORTED A PATIENT PRESENTED 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 24690974 ↗
• 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. AFFECTED SIDE: RIGHT KNEE.

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

  MAUDE report 24164363 ↗
• 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 23730106 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AS ASPIRATION POST SPACER AND WAS FOUND TO NOW BE GROWING YEAST. SURGEON CHOSE TO REPLACE THE EXISTING SPACER AND TREAT FOR YEAST. ALL COMPONENTS WERE FOUND TO BE INGROWN, DESPITE THE PRESENCE OF YEAST. ALL WERE REMOVED AND NEW COMPONENTS WERE PLACED WITH ANTIBIOTIC CEMENT AND RESORBABLE BEADS TO ADDRESS YEAST. UPON INSERTING THE NEW COMPONENTS ON THE FEMORAL SIDE, A FRACTURE WAS NOTED, DESPITE A CABLE BEING PLACED PRIOR TO PREP AND INSERTION. COMPONENTS WERE EXCHANGED AND A LONGER STEM AND AN ADDITIONAL CABLE WAS PLACED TO ADDRESS THE FRACTURE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE. THIS REPORT IS RELATED (B)(4) WHICH CAPTURES THE FRACTURE DURING INSERTION OF NEW DEVICES.

  Patient problems: Unspecified Infection

  MAUDE report 23697826 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UNFORTUNATELY, THE PATIENT WAS STILL INFECTED AND DRAINED SO THE SPACER WAS BEING EXCHANGED IN HOPES TO CLEAR THE INFECTION. NO DELAY NOR PATIENT HARM WAS NOTED.

  Patient problems: Unspecified Infection

  MAUDE report 23592630 ↗
• 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 23477234 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DESPITE REPEATED ATTEMPTS TO CURE THE SYSTEMIC INFECTION THIS PATIENT HAD, PATIENT CONTINUED TO SHOW INFECTION AND IT WAS DECIDED TO REMOVE THE IMPLANTS IN HIS RIGHT LEG AND PERFORM AN ABOVE KNEE AMPUTATION. ALL COMPONENTS PERFORMED AS EXPECTED TO THERE WAS NO ALLEGATION AGAINST THE COMPONENTS. THIS SUBMISSION IS BEING MADE AS THE IMPLANTS WERE REMOVED. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 22688975 ↗
• 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 22441203 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BEGAN TO DRAIN AGAIN POST ANTIBIOTIC SPACER FASHIONED WITH LPS COMPONENTS. ALL COMPONENTS WERE REMOVED. DURING DISSECTION AND REMOVAL, A VASCULAR INJURY OCCURRED. THE VASCULAR TEAM CAME IN TO REPAIR THE VESSELS. A NEW SPACER UTILIZING LPS COMPONENTS WAS PLACED AFTER A THOROUGH DEBRIDEMENT AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. THERE WAS A DELAY IN THE PROCEDURE AND HARM DID OCCUR BUT THERE WAS NO MENTION OF ALLEGATION AGAINST ANY DEPUY COMPONENTS CAUSING SAID INJURY. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE .

  Patient problems: Fluid Discharge; Perforation of Vessels

  MAUDE report 20239603 ↗
• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD BEEN DOING WELL POST SPACER. BEGAN HAVING PAIN A FEW DAYS PRIOR TO STATED SURGERY DATE. XRAYS WERE UNREMARKABLE. PATIENT TAKEN TO OR AND FOUND THAT THE FEMORAL SLEEVE HAD BECOME LOOSE. IN THE PROCESS OF SEPARATION AND REMOVAL, THE TIBIAL SIDE WAS ALSO REMOVED. A THOROUGH DEBRIDEMENT AND IRRIGATION WAS PERFORMED. FEMUR AND TIBIA WERE THEN PREPARED FOR A NEW SPACER UNEVENTFULLY AND RESORBABLE ANTIBIOTIC BEADS WERE PLACED ALONG WITH THE NEW SPACER. NO PATIENT HARM OCCURRED. NO DELAY WAS EXPERIENCED. DOI: (B)(6), 2023. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 18517771 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION PRESENT WITHIN KNEE. CONVERTED TO ABX SPACER. IT IS UNKNOWN IF ANY LOOSENING. THERE IS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2021. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 14514180 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ARTICLE ENTITLED "IS A SINGLE DOSE OF PREOPERATIVE ANTIBIOTIC THERAPY EFFECTIVE FOR PATIENTS TREATED WITH MEGAENDOPROSTHESIS AFTER METASTATIC BONE TUMOUR RESECTION?" WRITTEN BY M. KIRAN, J. ALSOUSOU, N. DALAL, P. RALTE, G. KUMAR, AND B. KAPOOR PUBLISHED BY MUSCULOSKELETAL SURGERY ON DECEMBER 16, 2020 WAS REVIEWED. THE AIM OF OUR STUDY WAS TO PRESENT THE RESULTS OF A SINGLE DOSE OF PREOPERATIVE ANTIBIOTIC ADMINISTERED DURING ANAESTHETIC INDUCTION IN A CONSECUTIVE COHORT OF PATIENTS UNDERGOING MPR FOR METASTATIC BONE DISEASE (MBD). 51 PATIENTS WERE INCLUDED IN THIS STUDY WHO UNDERWENT PRIMARY MEGAENDOPROSTHETIC REPLACEMENT (MPR) FOR MBD BETWEEN AUGUST 2012 AND SEPTEMBER 2018. ALL PATIENTS WERE IMPLANTED WITH DEPUY LPS. THE EXACT IMPLANTS IMPLANTED WERE NOT NOTED. 35 PATIENTS WERE IMPLANTED WITH A PROXIMAL FEMORAL REPLACEMENT. 7 PATIENTS WERE IMPLANTED WITH A DISTAL FEMORAL REPLACEMENT. 4 PATIENTS WERE IMPLANTED WITH A PROXIMAL HUMERAL REPLACEMENT. 3 PATIENTS WERE IMPLANTED WITH A DISTAL HUMERAL REPLACEMENT. 2 PATIENTS WERE IMPLANTED WITH A TOTAL FEMORAL REPLACEMENT. ADVERSE EVENTS: ONE CASE OF SUPERFICIAL WOUND INFECTION WHICH RESOLVED WITH TWO WEEKS OF ORAL CLINDAMYCIN. ONE CASE OF

  Patient problems: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 14186267 ↗
• InjuryNov 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO FEMUR WAS USED. THIS IS AN UNCEMENTED DEVICE, HOWEVER CEMENT IS UTILIZED TO COAT THE SPACER FOR THE PURPOSE OF ANTIBIOTIC DELIVERY. BOTH SLEEVES SUBSIDED FROM THE ORIGINAL POSITION THEY WERE PLACED CONSIDERING THEIR POSITION ON X-RAY, HOWEVER IT WAS THE FEMORAL SIDE SLEEVE WAS MOVING AT THE TIME OF SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 12749939 ↗
• InjuryAug 17, 2021Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A SPACER MADE OF LPS IMPLANT TO TREAT CHRONIC INFECTION. SEGMENTS DISASSOCIATED AND PATIENT WAS BROUGHT TO OPERATING ROOM. A THROUGH I&D WAS PERFORMED. SEGMENTS WERE DRIED AND IMPACTED TOGETHER. MANY ATTEMPT TO SEPARATE THE SEGMENTS WERE PERFORMED WITH NO MOVE TO AT ANY JUNCTION. ANTIBIOTIC BEADS WERE PLACED AND PATIENT WAS CLOSED UNEVENTFULLY. THE DISASSOCIATION OCCURRED BETWEEN THE LISTED SEGMENTS. DOI: (B)(6) 2021. DOR: (B)(6) 2021; RIGHT KNEE.

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

  MAUDE report 12330653 ↗
• InjuryAug 2, 2021Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD REPEATED REVISIONS AND COMPONENT EXCHANGES FOR INFECTION INVOLVING DEPUY PRODUCTS.

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

  MAUDE report 12263710 ↗
• InjuryApr 13, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SEGMENTS SEPARATED AT JUNCTION, SO DOCTOR TOOK ALL SEGMENTS OUT AND USED A 35 INSTEAD OF 30 TO ADD LENGTH. DOI: (B)(6) 2021, DOR: (B)(6) 2021, UNKNOWN AFFECTED SIDE.

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

  MAUDE report 11656725 ↗
• InjuryJun 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SPACER PLACED LAST (B)(6). HE CAME IN WITH INCREASED PAIN AND ELEVATED LABS. BROUGHT TO OR FOR I&D AND POSSIBLE COMPONENT CHANGE. SEGMENTS WERE EXCHANGED AND SLEEVE AND STEM WERE WELL FIXED AN LEFT IN PLACE. A THOROUGH DEBRIDEMENT WAS PERFORMED AS WELL AS PLACEMENT OF ANTIBIOTIC BEADS AND CEMENT. DOI: (B)(6) 2019, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 10134217 ↗
• InjuryMay 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS HETEROTOPIC OSSIFICATION. A THOROUGH I&D WAS PERFORMED WITH REMOVAL OF HETEROTOPIC OSSIFICATION AND PLACEMENT OF ANTIBIOTIC CEMENT AND BEADS. THE PATIENT IS STILL DRAINING. MODULAR COMPONENTS WERE EXCHANGED, STEMS WERE WELL FIXED AND WERE LEFT IN PLACE. DOI: (B)(6) 2020. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: Extraskeletal ossification; Fluid Discharge; No Code Available; Unspecified Infection

  MAUDE report 10049239 ↗