BIOMET ILOK PRI TIBIAL TRAY 83MM
Received Dec 2, 2020 · Event occurred Nov 12, 2020
Report 0001825034-2020-04252 · MDR key 10934946
Device
Generic name
Prosthesis, Knee
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
141216
Lot number
323010
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Unspecified Infection
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
(B)(4). DURING THE INVESTIGATION PROCESS A REVIEW OF THE STERILE CERTIFICATIONS WERE REVIEWED AND FOUND TO BE CONFORMING WITH NO APPLICABLE DEVIATIONS. DEVICES WERE VERIFIED TO HAVE GONE THROUGH ACCEPTABLE STERILIZATION PROCESS FOLLOWING ISO/AAMI/ASTM & EU PUBLISHED GUIDELINES. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS, I.E. HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUES IDENTIFIED AFFECTING IMPLANT SAFETY OR EFFECTIVENESS, THEREFORE IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION, FOR PRODUCTS WITH KNOWN PART/LOT INFORMATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
(B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM 189122 LOT 919030. ITEM 141316 LOT 065580. ITEM 184788 LOT 345980. ITEM UNKNOWN LOT UNKNOWN VANGUARD FEMORAL. REPORT SOURCE: FOREIGN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE HOSPITAL WILL NOT ALLOW RELEASE OF THE PRODUCT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-04251, 0001825034-2020-04253, 0001825034-2020-04254, 0001825034-2020-04255.
Description of Event or Problem
IT WAS REPORTED PATIENT UNDERWENT A KNEE REVISION PROCEDURE. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION THREE MONTHS LATER DUE TO INFECTION AS PER CULTURES TAKEN DURING THE REVISION. IMPLANTS REMOVED, WASHED WITH PULSE LAVAGE AND A FIRST STAGE IMPLANT WAS IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.