LPS 1987-07-045Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295078555), received between Sep 5, 2018 and Aug 3, 2026 — classified as 20 injuries, 1 malfunction.

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 16, 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.

• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pain.Affected side: Left knee.

  Patient problems: Pain

  MAUDE report 50116767 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REMOVING A PROXIMAL TIBIAL REPLACEMENT DUE TO CEMENTED STEM FRACTURE BREAK. UPON REMOVAL THE SURGEON INDICATED AN INCREASED AMOUNT OF POLYETHYLENE WEAR WHICH IN TURN CREATED METALOSIS IN THE JOINT. THE SURGEON BELIEVES THE POLY WEAR MAY HAVE LEAD TO THE FAILURE. DOI: ON (B)(6) 2015, DOR: ON (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Foreign Body Reaction

  MAUDE report 24429327 ↗
• InjuryJan 12, 2026Naturally Worn

  METALLOSIS CAUSED BY THE JUNCTION OF THE DFR IMPLANTS. MORE SPECIFICALLY, THE FEMORAL COMPONENT (MADE OF COBALT CHROME) AND THE SEGMENT (MADE OF TITANIUM), WHICH SEEMED TO HAVE CAUSED LYSIS AND INFECTION OVER TIME BECAUSE OF THE NEGATIVE IMPLANT WEAR. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Foreign Body Reaction; Osteolysis; Unspecified Infection

  MAUDE report 24040320 ↗
• 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 22071116 ↗
• 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 21314295 ↗
• MalfunctionJun 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT STATED THAT ON (B)(6) 2023 THE PATIENT HAD A COMPLEX LEFT KNEE REVISION WITH REMOVAL OF UNKNOWN MANUFACTURED PRODUCTS. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. SINCE THAT TIME, THE PATIENT HAS BEEN EXPERIENCING PAIN, AND A SENSATION OF KNEE LOCKING UP/ROTATING. THE PATIENT SAW A SURGEON WHO NOTED THAT THERE WAS A FAILED JUNCTION ALLOWING THE FEMORAL STEM TO ROTATE. DOI: (B)(6) 2023. DOR: UNKNOWN (LEFT KNEE).

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 19613537 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO STILL DRAINING AND SURGEON ELECTED TO WASH OUT AND CHANGE COMPONENTS THAT HE WAS ABLE TO. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 16417845 ↗
• InjuryJan 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS PERSISTENT BLOODY EFFUSION SINCE LAST SURGERY. SURGEON CHOOSES SURGICAL EXPLORATION AND I&D AS TREATMENT. LITTLE IS FOUND AND FROZEN SECTIONS ARE NEGATIVE. PATIENT DOES "OOZE" BUT NOT BLEEDERS FOUND. SURGEON NOTES MOTION LESS THAN HE WOULD PREFER AND CHOOSES TO REDUCE THE FEMORAL LENGTH BY CHANGING SEGMENTS. NO PATIENT HARM WAS NOTED. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge; Swelling/ Edema

  MAUDE report 16231767 ↗
• InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A DVT IN HER ARM FROM A PIC LINE POST OPERATIVELY. SHE WAS ANTICOAGULATED AND CAUSED A SWELLING IN HER KNEE. INCISION UNFORTUNATELY CAME OPEN DUE TO INCREASED SWELLING AND AN I&D WAS PERFORMED. SURGEON CHOSE TO EXCHANGE MODULAR COMPONENTS AT THE TIME OF SURGERY. NO PATIENT HARM OCCURRED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Swelling/ Edema; Wound Dehiscence

  MAUDE report 15804080 ↗
• InjuryFeb 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOI (B)(6) 2014: THE INFECTION WAS CLEARED AND AN LPS DISTAL FEMUR, SEGMENT COMPONENT, SLEEVE ADAPTOR, FEMORAL SLEEVE, LPS TIBIAL HINGE INSERT, UNIVERSAL STEM, MBT TRAY, MBT SLEEVE, AND UNIVERSAL STEM (SEE ADDITIONAL INFORMATION PROVIDED WITH PART/LOT) WAS IMPLANTED. A FREE LATISSIMUS DORSI FLAP WITH VEIN GRAFTING TO CORRECT A LEFT KNEE SKIN DEFECT PRESENT BEFORE THE REVISION WAS ALSO PERFORMED. POSTOPERATIVELY, THE DEVELOPED ACUTE RENAL FAILURE REQUIRING INCREASING IV FLUIDS. THIS WAS CAPTURED IN (B)(4). ON (B)(6) 2014: THE LATISSIMUS DORSI FLAP IS POSITIVE FOR PSEUDOMONAS AND STENOTROPHOMONAS MALTOPHILIA REQUIRING IV ANTIBIOTICS AND A WOUND VAC DRESSING TO ADDRESS THE DRAINAGE. THE INFECTION IS CLEARED THOUGH THE PATIENT IS TOLD TO REMAIN ON CHRONIC ANTIBIOTICS. THIS WAS CAPTURED IN (B)(4). ON (B)(6) 2014: THE EXTENSOR MECHANISM HAS ¿SLID PROXIMALLY¿ CAUSING BONE GRAFT TO COME LOOSE AND PATELLA TO RIDE HIGH PER RADIOGRAPHS IN REFERENCE TO HIS ALLOGRAFT RECONSTRUCTION WITH RESIDUAL ROM AND STRENGTH DEFICITS. NO SURGICAL INTERVENTION IS TO BE DONE. HE IS TO CONTINUE PHYSICAL THERAPY ONLY. THIS WAS CAPTURED IN (B)(4). EARLY (B)(6) 2014: THE PATIENT SUSTAINS A FALL DUE TO A SENSE OF

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 13584020 ↗
• InjuryFeb 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOI (B)(6) 2014: THE INFECTION WAS CLEARED AND AN LPS DISTAL FEMUR, SEGMENT COMPONENT, SLEEVE ADAPTOR, FEMORAL SLEEVE, LPS TIBIAL HINGE INSERT, UNIVERSAL STEM, MBT TRAY, MBT SLEEVE, AND UNIVERSAL STEM (SEE ADDITIONAL INFORMATION PROVIDED WITH PART/LOT) WAS IMPLANTED. A FREE LATISSIMUS DORSI FLAP WITH VEIN GRAFTING TO CORRECT A LEFT KNEE SKIN DEFECT PRESENT BEFORE THE REVISION WAS ALSO PERFORMED. POSTOPERATIVELY, THE DEVELOPED ACUTE RENAL FAILURE REQUIRING INCREASING IV FLUIDS. THIS WAS CAPTURED IN (B)(4). (B)(6) 2014: THE LATISSIMUS DORSI FLAP IS POSITIVE FOR PSEUDOMONAS AND STENOTROPHOMONAS MALTOPHILIA REQUIRING IV ANTIBIOTICS AND A WOUND VAC DRESSING TO ADDRESS THE DRAINAGE. THE INFECTION IS CLEARED THOUGH THE PATIENT IS TOLD TO REMAIN ON CHRONIC ANTIBIOTICS. DOI: (B)(6) 2014; DOE: (B)(6) 2014; AFFECTED KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13535245 ↗
• InjuryFeb 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOI (B)(6) 2014: THE INFECTION WAS CLEARED AND AN LPS DISTAL FEMUR, SEGMENT COMPONENT, SLEEVE ADAPTOR, FEMORAL SLEEVE, LPS TIBIAL HINGE INSERT, UNIVERSAL STEM, MBT TRAY, MBT SLEEVE, AND UNIVERSAL STEM (SEE ADDITIONAL INFORMATION PROVIDED WITH PART/LOT) WAS IMPLANTED. A FREE LATISSIMUS DORSI FLAP WITH VEIN GRAFTING TO CORRECT A LEFT KNEE SKIN DEFECT PRESENT BEFORE THE REVISION WAS ALSO PERFORMED. POSTOPERATIVELY, THE DEVELOPED ACUTE RENAL FAILURE REQUIRING INCREASING IV FLUIDS. DOE: (B)(6) 2014.

  Patient problems: Renal Failure

  MAUDE report 13535057 ↗
• InjuryFeb 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN KNEE SIDE.

  Patient problems: Ambulation or Postural Difficulties; Fall; Pain; Scar Tissue; Unspecified Infection

  MAUDE report 13534867 ↗
• InjuryOct 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. CEMENT IS HOSPITAL INVENTORY SO NO PART, LOT OR QUANTITY IS AVAILABLE IN MY RECORDS. SURGEON ROUTINELY USES DEPUY 2 WITH GENT IN HIS REVISION PROCEDURES B. (B)(6) 2020. C. LOOSENING IS UNEXPLAINED. THE SURGEON SUSPECTED INFECTION BUT CULTURES WERE NOT POSITIVE FOR INFECTION.

  Patient problems: Blister; Unspecified Infection

  MAUDE report 12712234 ↗
• InjuryAug 14, 2020Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED DUE TO FALL AND LOOSENING OF THE FEMUR & STEM COMPONENT AT THE BONE TO IMPLANT INTERFACE. CEMENT MANUFACTURER USED WAS UNKNOWN. PATIENT HAD LPS IMPLANTED IN (B)(6) 2019. PATIENT WAS REVISED USING CEMENTED LPS STEM. DOI: (B)(6) 2019 DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10410567 ↗
• InjuryJul 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE UNKNOWN COMPONENT AT THE BONE TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT BECAME INFECTED, SO IMPLANTS WERE REMOVED AND A ONE STAGE FUSION WAS IMPLANTED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10323223 ↗
• 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 10049235 ↗
• InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTED LPS REVISION KNEE. SURGEON REMOVED THE SEGMENTS AND DISTAL FEMUR AND REPLACED WITH SIMILAR PARTS TO WHAT THEY TOOK OUT EXCEPT FOR A 5MM LONGER SEGEMENT. SURGEON WASHED OUT EXTENSIVELY THE DISTAL FEMUR REGION OF THE LEG. DOI: (B)(6) 2018; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9383236 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DISTAL FEMORAL COMPONENTS REMOVED DUE TO INFECTION. LPS POLY AND HINGE PIN THAT WERE PLACED ON (B)(6) 2019 REMOVED, TIBIAL AND PATELLAR COMPONENTS REMOVED THAT WERE PLACED (B)(6) 2017. DOI: (B)(6) 2019 (FEMORAL COMPONENTS); DOI: (B)(6) 2019 (LPS POLY AND HINGE PIN); DOI: (B)(6) 2017 (TIBIAL AND PATELLA COMPONENTS); DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9379258 ↗
• InjuryMay 14, 2019Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAVING PATELLA AND FEMORAL ISSUES TO INCLUDE DISLOCATION. SEGMENT SHORTENED AND FEMORAL ROTATION INCREASED.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8607366 ↗
• InjurySep 5, 2018Separation Problem; Separation Problem

  IT WAS REPORTED THAT PATIENT HAD A KNEE FUSION PROCEDURE. THE PATIENT WAS TRANSFERRED TO THE FLOOR. THE NURSING STAFF HAD MOVED THE PATIENT AND PULLED ON THE LEG AND THE SEGMENTS CAME APART. THE SURGEON REOPENED THE INCISION TO REDUCE. THE SURGEON DECIDED TO GO A 1 CM LONGER. A SEGMENT WAS REMOVED AND TWO SEGMENTS WERE IMPLANTED TO ADD LENGTH. THE PATIENT WAS REDUCED AND SEGMENT TAPERS WERE ENGAGED. DOI: UNKNOWN. DOR: (B)(6) 2018. RIGHT KNEE.

  Patient problems: Not Applicable

  MAUDE report 7845605 ↗