LCS COMPLETE 1294-09-640Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295022640), received between Nov 14, 2017 and Oct 27, 2022 — classified as 12 injuries.

The most frequently reported specific device problem is “Fracture” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryOct 27, 2022Fracture; Naturally Worn; Fracture; Naturally Worn

  LCS COMPLETE STD POLY AND PATELLA REVISION. PATIENT WAS EXPERIENCING PAIN DUE TO DELAMINATION AND WEAR OF THE POLY AND OXIDISATION. AS A RESULT REQUIRED REMOVAL OF OLD POLY AND INSERTION OF NEW. WHILST INTRAOP LOOSE BIT OF THE OLD POLY INSERT DUE TO THE DELAMINATION FOUND POSTERIOR IN PATIENTS TISSUE. DOI: (B)(6) 2005. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Pain

  MAUDE report 15680506 ↗
• InjuryApr 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. NO DELAY IN SURGERY REPORTED. DOI: (B)(6) 2010, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11664605 ↗
• InjuryJul 14, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE POLY PORTION OF THE METAL-BACKED PATELLA HAS CRACKED AND HAS CAUSED THE PATELLA TO MOVE. THE PATELLA WAS REMOVED AND REPLACED WITH AN ALL-POLY PATELLA. DOI: (B)(6) 2014, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10271196 ↗
• InjuryJul 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT SIDE SUPERFICIAL PUS AND WOUND OOZE. PT WASHED OUT AND NEW POLY AND PATELLA POLY INSERTED. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES. REASON FOR REVISION SURGERY: INFECTION. PATIENT STATUS/ OUTCOME / CONSEQUENCES? YES.

  Patient problems: Inflammation; No Code Available; Unspecified Infection

  MAUDE report 8842560 ↗
• InjuryMar 25, 2019Naturally Worn; Naturally Worn

  REVISION BEARING AND POLY ON PATELLA. ORIGINAL SURGERY 2011. PT EXPERIENCED POSTERIOR CAPSULE LAXITY/ HYPEREXTENSION AND GRABBING PAIN. LCS STD INSITU AND REPLACED WITH POLY ON PATELLA (NO CHANGE OF THE METAL BACK) AND A THICKER BEARING (FROM 12.5MM TO 20MM). DETAILS OF IMPLANTS FROM 2011 AND ALSO IMPLANTS USED FOR THE REVISION.

  Patient problems: No Code Available; Pain

  MAUDE report 8448860 ↗
• InjurySep 20, 2018Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  PATIENT REPORTED A PAINFUL KNEE POST PATELLA RESURFACING SURGERY. X-RAYS SHOWED A TILTED PATELLA. UPON OPENING THE KNEE METALLOSIS WAS EVIDENT AND THE PATELLA POLY HAD POPPED OUT OF THE CORRECT POSITION AND THE PIN HAD LOCKED INTO A NEW POSITION IN THE POLY. THIS LOCKED THE PATELLA POLY INTO A NEW POSITION WHERE IT WAS NOT FREE TO MOVE. THE METAL BACK WAS ALSO DAMAGED FROM BEING EXPOSED TO THE FEMORAL COMPONENT AND RUBBING ON IT, CAUSING THE METALLOSIS.

  Patient problems: No Code Available; Pain; Tissue Damage

  MAUDE report 7896359 ↗
• InjurySep 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION FOR PAIN. PRIMARY KNEE INSERT WITH PATELLA NOT RESURFACED. PATIENT WENT ON TO HAVE PATELLA KNEE PAIN. ACTION TAKEN: REPLACE THE PATELLA.

  Patient problems: Not Applicable; Pain

  MAUDE report 7894876 ↗
• InjuryAug 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAINFUL KNEE. REMOVED METAL BACKED PATELLA AND INSERTED A LOW PROFILE POLY PATELLA. DOI: UNK; DOR: (B)(6) 2018 RIGHT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7832064 ↗
• InjuryAug 20, 2018Fracture; Fracture

  IT WAS REPORTED THAT ACCORDING TO SURGEON, PATIENT WAS JOGGING TO CROSS A STREET WHEN THEY HEARD AND FELT THEIR KNEE CAP POP. SURGEON DECIDED TO DO A PATELLA REVISION AND REPLACE DAMAGED PATELLA. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT SIDE.

  Patient problems: Not Applicable

  MAUDE report 7796779 ↗
• InjuryJun 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION: DR (B)(6), (B)(6) HOSPITAL, (B)(6) 2018. PRIMARY IMPLANT DATE: (B)(6) 2016. PATIENT HAD PAIN AND STIFFNESS POST TKA. BONE SCAN SHOWED INCREASED UPTAKE IN KNEE. SURGEON REVISED FEMORAL IMPLANT AND INSERT. PRODUCT CODE: 129409640 /LOT # 8271658: POLY CHANGE ON PATELLA, METAL BACK STILL IMPLANTED; LOOSE FEMORAL COMPONENT, LOW GRADE INFECTION - AWAITING RESULTS. FEMALE PATIENT (B)(6).

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7560373 ↗
• InjuryDec 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PATIENT HAD ORIGINAL SURGERY APPROX 12 MONTHS AGO AND WAS ADMITTED TO HOSPITAL A FEW DAYS AGO WITH SEVERE PAIN AND WAS UNABLE TO WEIGHT BARE. NO EVIDENCE OF INFECTION INTRA-OPERATIVELY OR IN BLOODS. DR TOOK MULTIPLE SPECIMENS. IMAGES AVAILABLE SHOW NO IN GROWTH ON ANY OF THE IMPLANTS REMOVED. ALL COMPONENTS WERE LOOSE - FEMORAL COMPONENT REMOVED BY HAND AND REPLACED WITH CEMENTED REVISION COMPONENTS.

  Patient problems: Pain

  MAUDE report 7075344 ↗
• InjuryNov 14, 2017Ambient Noise Problem; Ambient Noise Problem

  THE PATIENT WAS REVISED TO ADDRESS PATELLA "CLUNKING".

  Patient problems: No Code Available

  MAUDE report 7029831 ↗