EXPLOR MODULAR RADIAL HEAD
Received Jun 17, 2024
Report 0001825034-2024-01615 · MDR key 19547449
Device
Generic name
Prosthesis, Elbow, Hemi-, Radial, Polymer
Manufacturer
Zimmer Biomet, Inc.Model number
NICatalog number
11-210031
Lot number
65737274
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Nausea
- Pain
- Swelling/ Edema
- Nausea
- Pain
- Swelling/ Edema
Narrative
Description of Event or Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; B6; D2; D4; G1; G3; G6; H1; H2; H3; H6. D4: EXPIRATION DATE CORRECTED. H6: PROPOSED ANNEX G CODE MECHANICAL (G04) HEAD. MEDICAL RECORDS CONFIRM THE REPORTED EVENT OF PAIN AND SWELLING. HOWEVER, THE REPORTED EVENT OF AN ALLERGIC REACTION IS NOT CONFIRMED AS THE IMPLANTS DO INCLUDE THE COMPOUNDS THAT THE PATIENT IS ALLERGIC TO (FERRIC FLUORIDE AND MANGANESE FLUORIDE). NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. RADIOGRAPHS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; B6; B7; D2; G1; G3; G6; H1; H2; H10. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
CMP-0940053 MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. ASSOCIATED REPORTS ARE AVAILABLE FOR THE APPLICABLE CONCOMITANT PRODUCTS BELOW IN THE D10 NARRATIVE. D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): - 11-210062 (66192759) - 11-210099 (341750) THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND THAT 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 REPORTED THAT FOLLOWING AN INITIAL LEFT RADIAL HEAD ARTHROPLASTY, THE PATIENT ALLEGED THAT THEY WERE EXPERIENCING PAIN, SWELLING, NAUSEA, WEAKNESS, AND A POSSIBLE ALLERGIC REACTION APPROXIMATELY FIVE (5) MONTHS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.