LCS COMPLETE 1294-09-760Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295022732), received between Nov 20, 2017 and Oct 25, 2022 — classified as 10 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE AND LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. ALL IMPLANTS REMOVED. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15666317 ↗
• InjuryJun 28, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN MEDIALLY IN THE PATELLA AREA. THE SURGERY SCHEDULED, FOUND A BONY GROWTH MEDIALLY AND POSSIBLY CAUSING SLIGHTLY ABNORMAL PATELLA TRACKING. OVERGROWTH REMOVED, RELEASES MADE AND POPPED IN A REPLACEMENT POLY ON METAL BACKED CEMENTED PATELLA BASE. SURGERY WAS SUCCESSFUL. THE CEMENT MANUFACTURER WAS NOT INDICATED. NO SURGICAL DELAY. DOI: (B)(6) 2007; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain; Unspecified Musculoskeletal problem

  MAUDE report 14842188 ↗
• InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS AND SCAR TISSUE. DOI: UNKNOWN. DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Adhesion(s); No Code Available; Osteolysis

  MAUDE report 9770036 ↗
• InjuryDec 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN, SWELLING AND INFECTION. THE INSERT AND PATELLA POLY WERE CHANGED DURING A WASHOUT FOR INFECTION. DOI: (B)(6) 2014. DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: Edema; No Code Available; Pain; Unspecified Infection

  MAUDE report 9526019 ↗
• InjuryMar 7, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A RED & SWOLLEN LEFT KNEE DUE TO A FALL. THE PATIENT HAS A LCS TOTAL KNEE REPLACEMENT IN THAT KNEE AND THE SURGEON SUSPECTED EITHER A FRACTURED PATELLA OR TORN TENDON. THE SURGEON OPENED THE LEFT KNEE CAPSULE, REMOVED THE LCS METAL-BACKED PATELLA, RE-DRILLED THE THREE PEG HOLES, AND CEMENTED ON A NEW, SIZE LARGE, ALL-POLY, LCS PATELLA IMPLANT. HE THEN REINFORCED THE PATELLA TENDON WITH FIBERWIRE SUTURE, IRRIGATED THE WOUND WITH COPIOUS AMOUNTS OF SALINE AND IRRISEPT, PERFORMED A RANGE OF MOTION EXERCISE, AND FINALLY, CLOSED THE WOUND. BECAUSE THIS WAS A RECENT TRAUMATIC INJURY, THE SURGEON DID NOT SUSPECT INFECTION AND HE DID NOT SEND JOINT FLUID OR TISSUE SPECIMENS TO THE LAB. THE PATIENT WAS GENERALLY HEALTHY WITH FEW ALLERGIES AND/OR CO-MORBIDITIES. DOI: 8 YEARS AGO; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Swelling

  MAUDE report 8400183 ↗
• InjuryDec 7, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S LATERAL PATELLA IS WORN.

  Patient problems: No Code Available

  MAUDE report 8142516 ↗
• InjuryApr 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  RIGHT KNEE REVISION. PATIENT COMPLAINED OF PAIN, SWELLING AND EFFUSIONS. REMOVED ALL IMPLANTS. ORIGINAL DATE OF SURGERY IS UNKNOWN. PATIENT CONSEQUENCE?: UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.

  Patient problems: Not Applicable; Pain; Swelling

  MAUDE report 7468211 ↗
• InjuryApr 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL KNEE. EXPLANTED AND PUT IN CEMENT SPACER. DOI: (B)(6) 2014. DOR: (B)(6) 2018 RIGHT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7388092 ↗
• InjuryDec 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: 2005. DOR: (B)(6) 2017. LEFT KNEE.

  Patient problems: Pain

  MAUDE report 7150732 ↗
• InjuryNov 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMUR AT THE BONE TO CEMENT INTERFACE. DEPUY CEMENT WAS USED.UPDATE (B)(6) 2017. MEDICAL RECORDS REVIEWED. PRIMARY OPERATIVE NOTES (B)(6) 2013 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REPLACEMENT DUE TO OSTEOARTHRITIS OF THE LEFT KNEE. PROCEDURE WAS COMPLETED WITHOUT COMPLICATION NOTED BY THE SURGEON. OFFICE NOTES (B)(6) 2017 INDICATE THE PATIENT PRESENTS DUE TO KNEE PAIN AS WELL AS A FEELING OF INSTABILITY AND POPPING. REVISION NOTES (B)(6) 2017 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION ARTHROPLASTY WITH REPAIR OF EXTENSOR MECHANISM TO THE PATELLA DUE TO FAILED TOTAL KNEE ARTHROPLASTY WITH LOOSENING OF THE FEMORAL COMPONENT. UPON ENTERING THE JOINT, THE SURGEON NOTES THE PATELLA ITSELF WAS DETACHED FROM THE PROXIMAL PORTION OF THE EXTENSOR MECHANISM AND ATTACHED ON DISTALLY TO THE PATELLAR TENDON. THE PATELLA, ASIDE FROM THE DISTAL POLE, WAS COMPLETELY LOOSENED FROM THE EXTENSOR MECHANISM AND QUADRICEPS TENDON AND SOME SMALL REMNANT OF THE PATELLA WERE NOTED PROXIMALLY. PRESUMABLE WERE FRACTURES THAT OCCURRED. THE PATELLA COMPONENT ITSELF WAS NOT LOOSE, THERE WAS EVIDENCE OF NECROSIS OF THE BONE AROUND THE SUPE

  Patient problems: Bone Fracture(s); Joint Disorder; Necrosis; No Code Available; Pain; Synovitis

  MAUDE report 7045796 ↗