SIGMA LCS COMPLETE POROCOAT 1294-32-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295025719), received between Oct 19, 2017 and Dec 10, 2021 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2021Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE TIBIAL COMPONENT WAS LOOSE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12975978 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Muscular Rigidity

  MAUDE report 12595514 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PAIN FOLLOWING A CYST THAT FORMED ON THE LATERAL FEMORAL CONDYLE. THIS NECESSITATED THE REMOVAL OF THE PROSTHESIS.

  Patient problems: Pain

  MAUDE report 11738121 ↗
• InjuryNov 9, 2020Malposition of Device; Malposition of Device

  REVISION OF A PRIMARY MBT TIBIAL TRAY, INSERT AND ADDING OF A PATELLA. MBT TRAY REVISED TO A MBT REVISION TRAY WITH STEM, A NEW INSERT AND WE ADDED A PATELLA. ORIGINAL CASE WAS DONE ON THE (B)(6) 2019 SIDE BEING RIGHT. SURGEON STATED THE REASON FOR THIS REVISION WAS MALPOSITION OF THE TRAY.

  Patient problems: No Code Available

  MAUDE report 10810141 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTED KNEE. REMOVAL OF ALL IMPLANTS. NO EXTRA SURGICAL TIME NEEDED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8550843 ↗
• 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 8448018 ↗
• InjuryOct 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  COMPLAINT DESCRIPTION: THE PATIENT WAS REVISED TO ADDRESS PAIN. UPDATE 9-22-2017 AND 9-27-2012. MEDICAL RECORDS REVIEWED. PRE- REVISION NOTES INDICATE UPON CLINICAL EXAMINATION, THE PATIENTS KNEE IS SWOLLEN. THERE IS A LARGE EFFUSION PRESENT. X-RAYS TAKEN REVEALED A LARGE AREA OF LYSIS IN THE ANTERIOR PART OF THE PEG IN THE TIBIA AND NO EVIDENCE OF ANY FRACTURE, HOWEVER IT DID LOOK EXPANSIVE. BRIEF REVISION OPERATIVE NOTE JUN 22, 2015 REVEALS THE PATIENT RECEIVED A FIRST STAGE EXCISION ARTHROPLASTY RIGHT KNEE. FINDINGS INCLUDE GROSS TIBIAL LYSIS, TIBIAL MEDIAL DEFECT BENEATH MCL, PATELLAR TENDON WITH TUBERCLE STILL ATTACHED. NO ANTEROMEDIAL BONE. CORTICAL SHEEL OF LOOSE FRACTURED ANTEROLATERAL TIBIA. THE SURGEON DETERMINED THE JOINT WAS NOT RECONSTRUCTABLE WITH TC3 & AUGMENTS DUE TO CONCERNS ABOUT UNDERLYING INFECTION. PROXIMAL TIBIAL 1ST STAGE CARRIED OUT WITH SPACER & DEBRIDEMENT. MEDICAL RECORDS INDICATE THE PATIENT WAS RE-IMPLANTED IN SEP 2015, IT IS UNKNOWN WHAT PRODUCTS WERE IMPLANTED AT THIS TIME. IT IS THEN INDICATED THAT A RIGHT TRANSTIBIAL AMPUTATION WAS PERFORMED ON (B)(6) 2015 DUE TO PERSISTENTLY INFECTED RIGHT PROXIMAL TIBIAL REPLACEMENT WITH GRAFT /FLAP BREAKDOWN. INS

  Patient problems: Bone Fracture(s); Joint Swelling; Osteolysis; Pain; Tissue Damage

  MAUDE report 6965308 ↗
• InjuryOct 19, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS IMPLANTED IN (B)(6) 2007 .(B)(6) 2013 PAIN AND STIFFNESS WITH AUDIBLE SQUEAKING. (B)(6) ¿ 1ST STAGE REVISION AS A PRECAUTION NO EVIDENCE OF INFECTION. (B)(6) - 2ND STAGE REVISION.

  Patient problems: Pain

  MAUDE report 6962773 ↗