EXPLOR 12X24 MM IMPLANT HEAD
Received Jul 1, 2024 · Event occurred Oct 10, 2016
Report 0001825034-2024-01723 · MDR key 19650871
Device
Generic name
Extremity Implant
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
11-210042
Lot number
854450
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Pain
- Pain
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AND STIFFNESS WHICH LED TO THE REMOVAL OF THE IMPLANTS. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.
Additional Manufacturer Narrative
(B)(4). D10 - MEDICAL PRODUCT: CATALOG #: 11-210063, EXPLOR 8X28MM IMPL STEM W/SCR, LOT # 695120. G2: NORWAY. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE HAS BEEN DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT WAS FURTHER REPORTED THAT THE PATIENT HAD INITIAL SURGERY APPROXIMATELY 10 YEARS AGO. SUBSEQUENTLY, THE PATIENT HAD A REVISION ABOUT 2 YEARS LATER DUE TO RADIAL IMPLANT PAIN, PAIN AND STIFFNESS, AND ELBOW JOINT DYSFUNCTION.
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
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
(B)(4). PROPOSED G-CODE: MECHANICAL (G04) - HEAD. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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.