LPS 1987-27-018Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295079361), received between Apr 29, 2019 and Aug 13, 2024 — classified as 17 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS UNABLE TO STRAIGHTEN LEG. SO SURGEON REVISED THE MODULAR COMPONENTS. DOI: UNKNOWN. DOR:(B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 19974370 ↗
• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED IN SURGEON'S OFFICE WITH SYMPTOMS OF AN ACUTE INFECTION. PATIENT WAS ADMITTED AND BROUGHT TO THE OR FOR REVISION OF MODULAR COMPONENTS, A THOROUGH IRRIGATION AND DEBRIDEMENT (I&D), AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. NO DELAY WAS EXPERIENCED AND NO PATIENT HARM WAS NOTED. DOI: (B)(6) 2019. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19374281 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE POLY SWAP, DUE TO A POSSIBLE INFECTION. SURGICAL DELAY IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17371377 ↗
• 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). (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). (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 INSTAB

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 13584017 ↗
• 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 13535279 ↗
• 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 13535060 ↗
• 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 13534869 ↗
• InjuryAug 26, 2021Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT PATIENT HAS A HISTORY OF LEFT TOTAL KNEE WITH DISTAL FEMORAL REPLACEMENT. PT NOW COMPLAINS OF SQUEAKING IN THE KNEE. THE PTS LEFT KNEE WAS OPENED AND NOTED TO HAVE A LARGE AMOUNT OF SOFT TISSUE IN THE PATELLA FEMORAL SPACE. THE +5 SPACER WAS REMOVED ALONG WITH THE DFR COMPONENT AND POLY. THESE WERE REVISED TO NEW COMPONENTS TO DISTALIZE FEMUR AND ADJUST THE EXTERNAL ROTATION OF THE COMPONENT. DOI: (B)(6) 2018; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 12369781 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. SURGEON ELECTED TO EXCHANGE POLY. DOI: UNKNOWN DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11657077 ↗
• InjuryOct 1, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO FALL AND RUPTURED ARTHROTOMY. BECAUSE OF THE OPEN CAPSULE AND SEVERITY OF THE FALL, THE POLY ON THE HINGED KNEE CAME OUT. THE HINGE RP POLY POST THAT GOES DOWN THE TIBIA TRAY, CAME ALL THE WAY OUT OF THE TIBIA AFTER THE PATIENT FELL. HINGE PIN AND POLY REMOVED AND WOUND WAS IRRIGATED. SURGEON DOWNSIZED TO A 16MM POLY AND WAS HAPPY WITH THE STABILITY AND PATELLA TRACKING, THEN CLOSED THE PATIENT UP. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Fall; No Code Available; Wound Dehiscence

  MAUDE report 10612836 ↗
• InjuryJul 30, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. A POLY SWAP AND HINGE PIN SWAP WAS DONE. NO SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10344641 ↗
• InjuryJun 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATING THAT THE AFFECTED SIDE WAS RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10112076 ↗
• InjuryMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO LAXITY, INSERT EXCHANGED TO THICKER INSERT. DOI: (B)(6) 2019. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10056660 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RUPTURED HER EXTENSOR MECHANISM. SURGEON REPAIRED MECHANISM AND CHANGED THE TIBIAL INSERT AND BUMPER TO THE SAME SIZE LPS TIBIAL INSERT AS INITIALLY IMPLANTED. DOI: (B)(6) 2019; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9741972 ↗
• InjuryFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLEASE NOTE, IT IS INDICATED WITHIN THE MEDICAL RECORDS THAT THE PATIENT HAS A RIGHT KNEE REPLACEMENT. COMPETITOR PRODUCTS WERE IMPLANTED AT THE PRIMARY SURGERY. DEPUY PRODUCTS WERE IMPLANTED IN THE RIGHT KNEE AT THE (B)(6) 2019 REVISION PROCEDURE. PATIENT SUSTAINED A RIGHT PERIPROSTHETIC DISTAL FEMUR FRACTURE, ORIF WITH PLATE AND SCREWS, RELATING TO COMPETITOR PRODUCTS ON (B)(6) 2018. IT IS INDICATED SHE CONTINUED TO HAVE PAIN, BURNING, SWELLING, SOFT TISSUE EDEMA AFTER THE ORIF. (AT THIS TIME DEPUY PRODUCT HAS YET TO BE INVOLVED). REVISION OPERATIVE NOTES (B)(6) 2019 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO FEMORAL BONE FRACTURE, FAILED HARDWARE AND FAILED COMPETITOR RIGHT TOTAL KNEE. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. (NO ALLEGATION OF DEFICIENCY AGAINST DEPUY PRODUCTS AT THIS TIME). ER NOTES (B)(6) 2019 INDICATE THE PATIENT PRESENTS WITH RIGHT LEG PAIN AND DIFFICULTY AMBULATING AFTER MECHANICAL FALL AT HOME. LABS REVEAL THE PATIENT IS DEHYDRATED. RADIOGRAPHS REVEAL BONE FRACTURES AT THE PROXIMAL FIBULA AND DISTAL TIBIA. THE HIP AND KNEE IMPLANTS ON THE RIGHT SIDE ARE NOTED TO BE INTACT WITH UNCHANGED POSITIONING.

  Patient problems: Edema; No Code Available; Pain; Wound Dehiscence

  MAUDE report 9681105 ↗
• InjuryDec 30, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT FELL AND THE POLY DISLOCATED. HINGE PIN AND POLY WERE REMOVED AND NEW POLY/PIN INSERTED. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9531837 ↗
• InjuryApr 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. POLY WAS EXCHANGED AND HINGE PIN WAS ALSO REPLACED. LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8561869 ↗