UNKNOWN GLENOID
Received Dec 21, 2023 · Event occurred Jan 12, 2024
Report 0001822565-2023-03748 · MDR key 18379809
Device
Generic name
Extremity Implants
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
N/A
Lot number
N/A
Product problems
- Insufficient Device Problem Information
- Loosening of Implant Not Related to Bone-Ingrowth
- Insufficient Device Problem Information
- Loosening of Implant Not Related to Bone-Ingrowth
Patient
NA · Female
- Erosion
- Insufficient Information
- Erosion
- Insufficient Information
Narrative
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
(B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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.
Additional Manufacturer Narrative
(B)(4). 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
IT WAS FURTHER REPORTED THAT THE PATIENT HAD INITIAL SURGERY APPROXIMATELY 2 YEARS AGO, SUBSEQUENTLY THE PATIENT HAD A REVISION PLANNED DUE TO THE GLENOID COMPONENT LOOSENING WHICH LED TO GLENOID EROSION.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT RIGHT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A PMI PRODUCT IN 3 WEEKS DUE TO AN UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.
Additional Manufacturer Narrative
(B)(4). H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. H3 OTHER TEXT: REMAINS IMPLANTED.