VERSA-DIAL 46X18X53 HUM HEAD
Report
- Report Number
- 0001825034-2021-03165
- Event Type
- Injury
- Date Received
- November 19, 2021
- Date of Event
- November 17, 2021
- Report Date
- November 8, 2022
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- HSD
- UDI-DI
- 00880304212220
- PMA / PMN Number
- K193038
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: EVIDENCE OF INTERVAL LINER WEAR AND SUPERIOR SUBLUXATION OF THE HUMERAL IMPLANT IN RELATION TO THE GLENOID IMPLANT. THERE IS NO FRACTURE OR EVIDENCE OF IMPLANT LOOSENING. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B3, B4, B5, D6, G3, G7, H1, H2, H10 THE FOLLOWING SECTION WAS CORRECTED: G2 G2: FOREIGN - SPAIN 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PROPOSED ANNEX G CODE: MECHANICAL (G04) - HEAD. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED SCRATCHES AND WEAR MARKS. THE RESULTS OF THE ORIGINAL INVESTIGATION HAVE NOT CHANGED, A DEFINITIVE ROOT CAUSE CANNOT 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.
(B)(4). FOREIGN: (B)(6). CONCOMITANT MEDICAL DEVICES: VERSA-DIAL 42X18X46 HUM HEAD CAT: 113032 LOT: 769270; COMP PRIMARY STEM 9MM MINI CAT: 113629 LOT: 131150; VERSA-DIAL/COMP TI STD TAPER CAT: 118001 LOT: 187910; VERSA-DIAL/COMP TI STD TAPER CAT: 118001 LOT: 187910. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. PRODUCT NOT RETURNED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO WEAR AND DISLOCATION OF THE IMPLANT. DURING THE PROCEDURE, THE SCREW HEADS WERE NOTED TO BE TOTALLY WORN THIS CAUSED THE BASEPLATE TO BE LOOSE. METALLOSIS WAS NOTED TO BE PRESENT. THE POLY WAS DISASSOCIATED AND THE HEAD WAS DENTED. A BONE GRAFT WAS NEEDED TO COMPLETE THE PROCEDURE.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO WEAR AND DISLOCATION OF THE IMPLANT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1741747 | VERSA-DIAL 46X18X53 HUM HEAD | SHOULDER, PROSTHESIS | HSD | ZIMMER BIOMET, INC. | 113042 | 043520 | 00880304212220 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention| H |