EXPLOR 14X24 MM IMPLANT HEAD
Received Jul 2, 2024 · Event occurred Aug 19, 2015
Report 0001825034-2024-01736 · MDR key 19654734
Device
Generic name
Extremity Implant
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
11-210043
Lot number
572570
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Failure of Implant
- Pain
- Failure of Implant
- Pain
Narrative
Additional Manufacturer Narrative
(B)(4). D10 - MEDICAL PRODUCT: CATALOG #: 11-210064, EXPLOR 9X30MM IMPL STEM W/SCR, LOT # 947750. 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 REPORTED THAT THE PATIENT EXPERIENCED PAIN AND CREPITATION IN ELBOW AT APPROXIMATELY 2.5 YEARS POST OP. RADIOLOGY SHOWED LOOSENING OF THE STEM AND THE PATIENT WAS REVISED. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.
Additional Manufacturer Narrative
(B)(4). UPDATED: B4, B5, D2, D4 (EXP DATE), D6A, G3, H1, H2, H4, H11. 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 INITIAL SURGERY WAS PERFORMED APPROXIMATELY 11 YEARS AGO.
Description of Event or Problem
VOIDING THE RADIAL HEAD AS THE PAIN IS RELATED TO THE LOOSENING OF HUMERAL STEM AND NOT WITH THE ARTICULATION OF THE HUMERAL HEAD.
Additional Manufacturer Narrative
(B)(4). PROPOSED G-CODE: MECHANICAL (G04) - HEAD. VOIDING THE RADIAL HEAD AS THE PAIN IS RELATED TO THE LOOSENING OF HUMERAL STEM AND NOT WITH THE ARTICULATION OF THE HUMERAL 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.