LCS COMPLETE POROCOAT 1294-03-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295021704), received between Aug 9, 2017 and Aug 25, 2026 — classified as 10 injuries, 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient underwent a revision procedure due to osteolysis and lateral distal bone loss on the femur. The LCS tibia was left insitu and Attune PS femur & Attune PS RP bearing + Attune Dome Patella were implanted with cement even though the surgeon was informed this was considered off label use. The bearing was able to fit into the tibia and was tested prior to implantation, however, due to the patient's scar tissues being very tight the surgeon had to trim the bearing to get access and fit it in and get around the condyles of the new femoral component; he was informed this was also off label use.

  Patient problems: Adhesion(s); Bone Notching; Osteolysis

  MAUDE report 50437807 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  Thayer School of Engineering at Dartmouth first report of retrievals for Statement of Work 10 for Q2 of 2026. (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 due to infection, pain, and debonded tibial component. The non-articular surface of the cemented tibial tray shows a minor retrieval artifact, sparse cement remaining, and relative motion between cement and metal although minor.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 50176751 ↗
• InjuryOct 21, 2024Osseointegration Problem; Osseointegration Problem

  ADDITIONAL EVENT INFORMATION STATES THAT THERE WAS NO ADVERSE EVENTS AND NO SURGICAL DELAY.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 20494985 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LCS REVISION DUE TO INFECTION AND PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 15735392 ↗
• InjuryJun 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. NO SURGICAL DELAY. DOI: (B)(6) 2017, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10137791 ↗
• InjuryDec 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO FLEXION CONTRACTURE AND STABILITY ISSUES. ALL COMPONENTS WERE REMOVED AND ATTUNE REVISION COMPONENTS WERE IMPLANTED. THE LOT NUMBERS ON THESE EXPLANTED COMPONENTS WERE NOT LEGIBLE EXCEPT FOR THE POLYETHYLENE BEARING. POROCOATED IMPLANTS WERE USED. DOI: UNKNOWN, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9467190 ↗
• MalfunctionSep 4, 2019Difficult to Open or Close; Device Difficult to Maintain; Difficult to Open or Close; Device Difficult to Maintain

  LCS FEMORAL IMPLANT WAS BEING OPENED BY NURSING STAFF, THE INNER STERILE PACKAGING WAS STUCK INSIDE THE OUTER PACKAGING. SCRUB NURSE NEEDED TO REMOVE THE PAPER COVERING OF THE INTERNAL PACKAGING TO ACCESS THE FEMORAL COMPONENT. THE PACKAGING IS STILL STUCK TOGETHER AND AVAILABLE FOR EXAMINATION IF REQUIRED.

  Patient problems: Not Applicable

  MAUDE report 8962272 ↗
• InjuryMar 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT ORTHOPEDIC SURGERY ON OR ABOUT (B)(6), 2017 AND (B)(6), 2017, AND WAS IMPLANTED WITH DEPUY SYNTHES DEVICES WHICH SUBSEQUENTLY MALFUNCTIONED OR FAILED, CAUSING PLAINTIFF INJURIES, DEBILITATION AND NECESSITATING FURTHER MEDICAL INTERVENTIONS.

  Patient problems: Injury; No Code Available; Pain

  MAUDE report 8448019 ↗
• InjuryJan 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION TOTAL KNEE REPLACEMENT. DR (B)(6), (B)(6) ; (B)(6) 2017. PATIENT UNDERWENT PRIMARY TKR (B)(6) 2009 (DR (B)(6), (B)(6)). PATIENT PRESENTED AT 6 MONTH FOLLOW UP WITH A SOMEWHAT STIFF KNEE. PATIENT HAS THEN DISAPPEARED FROM FOLLOW UP AND HAS PRESENTED RECENTLY WITH A PAINFUL AND STIFF KNEE, WITH A RANGE OF MOTION OF 15-45 DEGREES. A DECISION WAS MADE TO REVISE THE KNEE. ON OPENING THE KNEE, THE COMPONENTS WERE WELL FIXED. RADIAL SCRATCHES WERE EVIDENT ON THE TIBIAL TRAY, ONCE THE INSERT HAD BEEN REMOVED. THE POSTERIOR CAPSULE WAS RELEASED ALONG WITH THE MOBILISATION OF THE MEDIAL AND LATERAL GUTTERS. ALL COMPONENTS WERE REMOVED AND A PFC TC3 RP IMPLANTED (WITH SLEEVES AND STEMS) THE KNEE WAS ABLE TO FULLY EXTEND AND PASSIVELY FLEX TO APPROXIMATELY 115 DEGREES. MALE PATIENT INITIALS (B)(6), AGED (B)(6), DOB (B)(6). DOI: (B)(6) 2009; DOR: (B)(6) 2017; UNKNOWN KNEE.

  Patient problems: Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 7160170 ↗
• InjuryAug 18, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN AND STIFFNESS.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 6803737 ↗
• InjuryAug 9, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6777531 ↗