LPS 1987-27-112Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10603295079392), received between Jul 20, 2017 and Apr 8, 2026 — classified as 35 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 35 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED. WASH OUT AND POLY SWAP WAS PERFORMED DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24822834 ↗
• InjuryApr 7, 2026Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: UNKNOWN, DOR: ON (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 24800394 ↗
• InjuryFeb 24, 2026Naturally Worn

  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 LED TO THE FAILURE. DOI: (B)(6) 2015. DOR:(B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Foreign Body Reaction

  MAUDE report 24429477 ↗
• InjuryDec 30, 2025Naturally Worn; Naturally Worn

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK FOR Q4 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION FOR PAIN. THE ARTICULAR SURFACE OF THE MOBILE-BEARING POLYETHYLENE TIBIAL INSERT SHOWS EMBEDDED METAL. SEVERE ABRASION NOTED AROUND BOTH SIDES OF THE BUSHINGS.

  Patient problems: Pain

  MAUDE report 23923062 ↗
• InjuryDec 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A PREVIOUS LEFT DISTAL FEMUR REPLACEMENT DONE ON AN UNKNOWN DATE. PATIENT DISLOCATED THE KNEE AND BROUGHT IN FOR REVISION. THE FEMORAL COMPONENT WAS LOOSE SO A NEW DISTAL FEMORAL COMPONENT AND INSERT WERE IMPLANTED. THE TIBIAL COMPONENT WAS NOT LOOSE AND WAS LEFT IN PLACE. THERE WAS NO DELAY IN SURGERY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 23783678 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAINED OF THIGH PAIN. THERE WAS A LUCENCY AROUND THE STEM ON X-RAY. OPERATIVELY, THE SLEEVE WAS WELL FIXED BUT SURGEON WAS CONCERNED AND REMOVED ALL FEMORAL COMPONENTS. TIBIAL COMPONENT APPEARED TO BE WELL FIXED AND WAS LEFT IN PLACE. A DISTAL FEMORAL REPLACEMENT WAS PLACED WITHOUT DELAY OR PATIENT HARM. DOI: ON (B)(6) 2017, DOR: ON (B)(6) 2025, AFFECTED SIDE-LEFT SIDE.

  Patient problems: Pain

  MAUDE report 23584894 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21115084 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION OF KNEE. POLY AND HINGE PIN SWAPPED OUT. DOI: (B)(6) 2019. DOR:(B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20825576 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PROGRESSIVE PAIN AND RECURRENT HEMARTHROSIS RIGHT KNEE. BONE SCAN IMPLIED COMPONENTS MAY BE LOOSE. THEY WERE NOT. DOI: (B)(6) 2019, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 19221252 ↗
• 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 17951302 ↗
• 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 17226214 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WASHOUT AND POLY EXCHANGE OF PATELLA AND LPS INSERT DUE TO INFECTION LEFT SIDE. PATIENT DECIDED TO WALK WITHOUT A ZIMMER FRAME AND FELL. SURGEON HAD RECEIVED SOME RESULTS PATIENT HAS A STAPH C INFECTION AND HAS BEEN MONITORING THE PATIENT, BUT WHEN THE PATIENT FELL YESTERDAY AFTERNOON HE DECIDED TO TAKE HIM INTO THE THEATRE TO CHECK THAT EVERYTHING WAS OK AS WELL AS DO A WASHOUT. SPECIMENS TAKEN DURING THE PROCEDURE.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 15924029 ↗
• InjurySep 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. PATIENT HAD PRIOR LEFT TOTAL FEMUR REPLACEMENT AND HAD PRESENTED WITH A DISLOCATED LEFT KNEE. THE POLY WAS DISLOCATED FROM THE TIBIAL CONSTRUCT. SURGEON REMOVED THE POLY INSERT AND REPLACED WITH A NEW ONE AND HE ALSO REMOVED A SEGMENT OF THE TOTAL FEMUR CONSTRUCT. I DO NOT KNOW THE SIZE OF THE LPS SEGMENT REMOVED. THERE WAS NO LOOSENING EXPERIENCED. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 15417127 ↗
• InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14549477 ↗
• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED AN I& D WITH A REVISION OF THE LEFT KNEE LPS HINGED INSERT TO TREAT PAIN AND SWELLING SECONDARY TO MRSA INFECTION. THE PATIENT WAS PLACED ON IV ANTIBIOTICS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2015. DOR: (B)(6) 2016. (LEFT KNEE).

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 13567755 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON REPORTED TO BFARM: "SUDDEN INCREASE OF PAIN IN THE LEFT KNEE JOINT AFTER A FALL EVENT."

  Patient problems: Fall; Pain

  MAUDE report 13558330 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2020, DOI: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 13023463 ↗
• InjuryOct 19, 2021Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO STRAIGHTEN THE LEG AND X-RAYS CONFIRMED THAT THE POLY POST HAD DISASSOCIATED FROM THE TIBIAL TRAY. SURGERY WAS PERFORMED AND THE TIBIAL INSERT WAS REMOVED. THE METAL ASPECT OF THE POLY WAS LOOSE AND DISASSOCIATED FROM THE POLY. DOI: (B)(6) 2021, DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 12655908 ↗
• InjuryMay 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED DUE TO INFECTION. POLY EXCHANGE WAS DONE. NO LOOSENING AND NO DELAY IN SURGERY REPORTED. DOI: (B)(6) 2021 DOR: (B)(6) 2021 RIGHT KNEE.

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

  MAUDE report 11761300 ↗
• InjuryApr 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE HINGE PIN WAS REMOVED AND NOT REPLACED. THE SURGEON PLACED AN ANTIBIOTIC SPACER IN THE KNEE. THE FEMORAL SLEEVE AND STEM WERE LEFT IMPLANTED.

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

  MAUDE report 11628952 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. POLY EXCHANGE WITH I & D PERFORMED. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.

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

  MAUDE report 10895514 ↗
• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL KNEE TO ADDRESS INFECTION. DATE OF PRIMARY: (B)(6) 2008 (NON-DEPUY PRODUCTS IMPLANTED). DATE OF REVISION #1: (B)(6) 2010 (INSTABILITY - FEMUR, TIBIAL TRAY, TIBIAL INSERT). DATE OF REVISION #2: (B)(6) 2012 (INFECTION - FEMUR, TIBIAL TRAY, TIBIAL INSERT, COMPETITOR. PATELLA 12 IPS CAPTURED ON (B)(4). DATE OF REVISION #3: (B)(6) 2013 (12 IPS CAPTURED ON (B)(4). (RIGHT KNEE). TREATMENT: REVISION OF FEMUR CONSTRUCT, TIBIAL TRAY CONSTRUCT, PATELLA, AND TIBIAL INSERT.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10836923 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON STATED THE PATIENT IS INFECTED. REPLACED POLY AND HINGE PIN. WASHED OUT WAS PERFORMED. DOI: (B)(6) 2020. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10684594 ↗
• InjuryApr 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS TREATED WITH A KNEE REPLACEMENT ON THE (B)(6) 2019. PATIENT WAS ADMITTED TO HOSPITAL DUE TO AN INFLAMMATION IN THE KNEE. REVISION SURGERY PLANNED FOR THE (B)(6) 2020. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Inflammation; No Code Available

  MAUDE report 10014838 ↗
• InjuryMar 31, 2020Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  REVISION OF UNKNOWN PARTS OF A LPS KNEE SYSTEM BECAUSE OF INLAY FAILURE.

  Patient problems: Hematoma; No Code Available; Pain; Swelling

  MAUDE report 9908097 ↗