NA 86-7433Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295217930), received between Jun 19, 2018 and May 10, 2021 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2021Material Deformation; Material Deformation

  UNIVERSAL STEM WAS DAMAGED DURING IMPLANT ASSEMBLY BY MISUSE. THE PRONGS WERE DEFORMED BY TIGHTENING THE EXTENSION WRENCH (865189) STRONGLY TO THE STEM IN THE PLACE BETWEEN THE SLOTS. THIS WAS DUE TO INSUFFICIENT EXPLANATION IN SURGICAL TECHNIQUE - THERE IS NO SPECIFIED PLACE TO USE THE WRENCH ON THE STEM. SURGERY DELAYED 5 MINUTES. PROCEDURE SUCCESSFULLY COMPLETED. NO FRAGMENTS GENERATED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797629 ↗
• InjuryJan 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND INSTABILITY. NO ADDITIONAL INFORMATION WAS AVAILABLE. DOI: (B)(6) 2016 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11251829 ↗
• InjuryFeb 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD REVISION FOR HAVING LOOSE COLLATERAL LIGAMENTS. DOI: UNKNOWN; DOR: (B)(6) 2020; LT KNEE.

  Patient problems: No Code Available

  MAUDE report 9688687 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS POSSIBLE INFECTION, STATUS POST FALL LEADING TO FEMUR FRACTURE, WOUND DEHISCENCE AND LOOSENING OF THE UNKNOWN COMPONENT AT THE BONE TO IMPLANT INTERFACE. UNKNOWN CEMENT MANUFACTURER WAS USED. TIBIAL BASE CEMENTED BUT NOT LOOSENED. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Bone Fracture(s); No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 9376007 ↗
• MalfunctionDec 21, 2018Delivered as Unsterile Product; Delivered as Unsterile Product

  THE 115X20MM STEM WAS OPENED AND THE INNER PACKAGING WAS STAINED - THE SECOND STERILE POUCH WAS ALSO STAINED AND THE SURGEON WAS UNSURE OF THE IMPLANT STERILITY AND COULD NOT USE THIS.

  Patient problems: Not Applicable

  MAUDE report 8188899 ↗
• MalfunctionDec 21, 2018Delivered as Unsterile Product; Delivered as Unsterile Product

  THE 115X20MM STEM WAS OPENED AND THE INNER PACKAGING WAS STAINED - THE SECOND STERILE POUCH WAS ALSO STAINED AND THE SURGEON WAS UNSURE OF THE IMPLANT STERILITY AND COULD NOT USE THIS.

  Patient problems: Not Applicable

  MAUDE report 8188891 ↗
• InjurySep 10, 2018Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; 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 7859778 ↗
• InjuryAug 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RE REVISION OF KNEE ARTHROPLASTY. PATIENT CONSEQUENCE? :UNKNOWN. PATIENT CONSEQUENCE DESCRIPTION:PAIN AND DIFFICULT TO WALK. ACTION TAKEN FOR PROCEDURE:CULTURES TAKEN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Pain

  MAUDE report 7741886 ↗
• InjuryJun 19, 2018Loss of Osseointegration; Loss of Osseointegration

  REVISION TOTAL KNEE REPLACEMENT, DR. (B)(6), (B)(6) 2018. REVISION OF REVISION LCS TKR DUE TO FEMORAL LOOSENING, TIBIA REMAINED INSTITU. PATIENT INITIALS: (B)(6). UNKNOWN JRN: LCS COMP RP LARGE 12.5MM REVISION. UNKNOWN JRN: LARGE FEMUR LEFT REVISION. UNKNOWN: JRN: 115 X 20 MM UNCEMENTED TIBIAL STEM.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7613039 ↗