SM HYBRID GLENOID BASE 4MM
Report
- Report Number
- 0001825034-2022-01966
- Event Type
- Injury
- Date Received
- August 29, 2022
- Report Date
- December 2, 2022
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- MBF
- UDI-DI
- 00880304462625
- PMA / PMN Number
- K193038
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-01967, 0001825034-2022-01968, 0001825034-2022-01969. MEDICAL PRODUCTS: ITEM#: UNKNOWN, UNKNOWN HUMERAL HEAD; LOT#: UNKNOWN. ITEM#: UNKNOWN, UNKNOWN HUMERAL STEM, LOT#: UNKNOWN. ITEM#: UNKNOWN, UNKNOWN REGENEREX POST; LOT#: UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-01967-1 0001825034-2022-01968-1 0001825034-2022-01969-1 0001825034-2022-02593 THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; B7; D1; D2; D4; D6; D10; G3; G4; G6; H1; H2; H3; H4; H6 D10: MEDICAL PRODUCTS: ITEM#: 113046, VERSA-DIAL 46X24X47 HUM HEAD; LOT#: 519180 ITEM#: 113631, COMP PRIMARY STEM 11MM MINI; LOT#: 527120 ITEM#: PT-113950, PT HYBRID GLEN POST REGENEREX; LOT#: 768240 ITEM#: 118001, VERSA-DIAL/COMP TI STD TAPER; LOT#: 223190 H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-01967-2, 0001825034-2022-01968-2, 0001825034-2022-01969-2, 0001825034-2022-02593-1. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION SURGERY FOR AN UNKNOWN REASON ON AN UNKNOWN DATE.
IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY APPROXIMATELY SIX (6) YEARS AGO. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION SURGERY DUE TO EXCESSIVE GLENOID RETROVERSION. HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1198865 | SM HYBRID GLENOID BASE 4MM | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES | MBF | ZIMMER BIOMET, INC. | 113952 | 592850 | 00880304462625 |
| 2593411 | SM HYBRID GLENOID BASE 4MM | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES | MBF | ZIMMER BIOMET, INC. | 113952 | 592850 | 00880304462625 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention| H |