LPS 1987-21-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295079071), received between Jul 21, 2017 and Feb 24, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 POLY ETHYLENE WEAR WHICH IN TURN CREATED METALOSIS IN THE JOINT. THE SURGEON BELIEVES THE POLY WEAR MAY HAVE LEAD TO THE FAILURE. DOI: (B)(6) 2015, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Foreign Body Reaction

  MAUDE report 24429200 ↗
• InjuryJul 19, 2022Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  PATIENT¿S PREVIOUS PROXIMAL TIBIA REPLACEMENT (2020), CONTINUING TO DISLOCATE POLY OUT OF PROX TIBIA COMPONENT. REVISION SURGERY DEMONSTRATED PROX TIBIA REPLACEMENT COMPONENT WAS ROTATED, CAUSING POLY INSERT TO DISLOCATE FROM POST. ALSO WHEN REMOVED, EVIDENCE OF METAL CHARRING IN THE IMPLANT NOTED, WHICH CAN LEAD TO METALOSIS OF COMPONENTS/TISSUE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. ACTION TAKEN WHEN EVENT OCCURRED? REPLACED PROXIMAL TIBIA COMPONENT, ADDED SEGMENTAL 25MM COMPONENT. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? YES. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. OTHER INFORMATION: METAL WEAR NOTED. PATIENT STATUS/ OUTCOME / CONSEQUENCES? YES. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? INFLAMMATION, DISLOCATIONS. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IF YES, DESCRIBE: ROTATION OF COMPONENT IN SEGMENTAL SLEEVE CAUSED REPEATED POLY INSERT DISLOCATIONS AND POTENTIAL METAL BREAKDOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (B)(6). DEVICE PROP

  Patient problems: Inflammation

  MAUDE report 15054835 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT FILLED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DRRA) FOR PATIENTS IMPLANTED WITH DEPUY SYN. (46) HIP COHORT- INVOLVING PROXIMAL FEMORAL BODY IMPLANT . (72) KNEE COHORT- INVOLVING DISTAL FEMUR IMPLANT. (13) TOTAL- INVOLVING BOTH PROXIMAL AND DISTAL IMPLANTS. (72) NONE- NOT REQUIRING THE PROXIMAL OR DISTAL IMPLANT. COMPLICATIONS SUSTAINED WITHIN 5 YEAR REVIEW: 53 PATIENTS SUSTAINED A SUBSEQUENT SURGERY AFTER THE PRIMARY IMPLANTATION OF LPS PRODUCTS. 76 PATIENTS HAD AN INFECTION AFTER THE PRIMARY IMPLANTATION OF LPS PRODUCTS. 75 PATIENTS HAD A MECHANICAL COMPLICATION AFTER THE PRIMARY IMPLANTATION OF LPS PRODUCTS.

  Patient problems: Unspecified Infection

  MAUDE report 14083790 ↗
• InjurySep 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: PATIENT CORRESPONDENCE STATES THAT THE PATIENT HAS A BROKEN DIAPHASEAL SLEEVE. ON 2/21/2017 - SALES REP ((B)(4)) WAS CONTACTED VIA PHONE AND EMAIL REGARDING THE REVISION SURGERY FOR THE PATIENT. AN EMAIL WAS SENT TO THE SALES REP WITH PRODUCT RETURN INSTRUCTIONS. PRODUCT SHOULD BE RECEIVED BY (B)(4). UPDATE 03/31/2017 ¿MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, THE MEDICAL RECORDS REPORT THAT THE KNEE ARTHROPLASTY FAILED AT THE DIAPHYSEAL TAPER JUNCTION OF THE STEM TIBIAL COMPONENT CAUSING THE PROXIMAL ASPECT TO BECOME GROSSLY LOOSE. THERE WAS NO NEW INFORMATION THAT WOULD AFFECT THE EXISTING MDR INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 04/18/2017. UPDATE APR 10, 2017 AND APRIL 24, 2017: MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, A DOI WAS PROVIDED AND LOT NUMBER WAS PROVIDED. THIS COMPLAINT WAS UPDATED ON: 5/1/2017. UPDATE MAY 15, 2017: LEGAL MEDICAL RECORDS RECEIVED. MEDICAL RECORDS HAVE BEEN REVIEWED. X-RAY IMPRESSION FROM (B)(6) 2016 INDICATES SUBSTANTIALLY INCREASED LUCENCY FROM THE COMPARED X-RAY ON (B)(6) 2016, ALONG THE

  Patient problems: Pain

  MAUDE report 7859721 ↗
• InjuryJul 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2017 DUE TO RIGHT KNEE PAIN, SWELLING, REDNESS AND DRAINAGE FOR 3 DAYS, FEVER, AND DECREASED RANGE OF MOTION. PATIENT HAD PREVIOUSLY HAD RIGHT KNEE REVISION SURGERY ON (B)(6) 2017. PATIENT HAS A COMPLICATED AND LONG SURGICAL HISTORY OF RIGHT KNEE. I&D AND REVISION OCCURRED ON (B)(6) 2017 DUE TO INFECTION. AT TIME OF REVISION THE SURGEON NOTED COPIOUS AMOUNTS OF OBVIOUS FRANK PUS WITHIN THE KNEE JOINT SPACE. DEVITALIZED TISSUE AND INFECTED TISSUE WAS SEEN THROUGHOUT. THOROUGH DEBRIDEMENT AND IRRIGATION WAS PERFORMED. MULTIPLE PRODUCTS WERE EXPLANTED AND REPLACED. AT 2 WEEK POST-OP ASSESSMENT ON (B)(6) 2017 PATIENT SHOWS NO SIGN ON INFECTION. THE RIGHT KNEE WOUND IS CONTINUING TO HEAL WITH SOME ERYTHEMA SURROUNDING THE INCISION WHICH APPEARS TO BE SOMEWHAT FROM THE WOUND VAC PLACEMENT, WHICH HAS BEEN REMOVED. THE SWELLING OF THE RIGHT KNEE HAS DECREASED SUBSTANTIALLY.

  Patient problems: Loss of Range of Motion; Pain; Unspecified Infection

  MAUDE report 6731470 ↗