COMP NLK SCR 3.5HEX 4.75X25 ST
Report
- Report Number
- 0001825034-2024-02366
- Event Type
- Injury
- Date Received
- October 8, 2024
- Report Date
- December 12, 2024
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- PHX
- UDI-DI
- 00880304555402
- PMA / PMN Number
- K130390
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: MEDICAL PRODUCTS: ITEM#: 010000589, COMP RVRS 25MM BSPLT HA+ADPTR; LOT#: 66053299; ITEM#: 115397, COMP RVS CNTRL 6.5X35MM ST/RST; LOT#: 66082758; ITEM#: 180559, COMP NLK SCR 3.5HEX 4.75X25 ST; LOT#: 66127676; ITEM#: 180562, COMP NLK SCR 3.5HEX 4.75X40 ST; LOT#: 859790; ITEM#: 180561, COMP NLK SCR 3.5HEX 4.75X35 ST; LOT#: 66138820; ITEM#: 115316, COMP RVRS SHLDR GLNSP +6 36MM; LOT#: 135990; ITEM#: 00-4349-010-17, TM REVERSE STEM 10MM X 170MM; LOT#: 65550644; ITEM#: 00-4349-036-00, 36MM POLY LINER PLUS 0MM OFS; LOT#: 65871436. 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. D10: MEDICAL PRODUCTS: ITEM#: 180562, COMP NLK SCR 3.5HEX 4.75X40 ST; LOT#: 919680 H10: RELATED REPORT NUMBERS: 0001825034-2024-02361-1 0001825034-2024-02362-1; 0001825034-2024-02363-1; 0001825034-2024-02364-1; 0001825034-2024-02365-1. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: REVERSE TOTAL SHOULDER ARTHROPLASTY WITH FRACTURE GLENOID SCREWS BUT NO DISLOCATION. SIZING IS APPROPRIATE. THERE ARE MULTIPLE FRACTURED GLENOID SCREWS FROM A REVERSE TOTAL SHOULDER ARTHROPLASTY. IT WAS NOTED THAT 5 PERIPHERAL SCREWS WERE INVOICED PER USAGE AND STICKER SHEETS. THE BASEPLATE ONLY HAS OPENINGS FOR 4. HOWEVER, IT IS UNKNOWN WHICH ITEM WAS NOT IMPLANTED AND WHY IT WAS NOT USED. AS SUCH, 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). D10: MEDICAL PRODUCTS: ITEM#: 010000589, COMP RVRS 25MM BSPLT HA+ADPTR; LOT#: UNKNOWN. ITEM#: 115397, COMP RVS CNTRL 6.5X35MM ST/RST; LOT#: UNKNOWN. ITEM#: 180559, COMP NLK SCR 3.5HEX 4.75X25 ST; LOT#: UNKNOWN. ITEM#: 180562, COMP NLK SCR 3.5HEX 4.75X40 ST; LOT#: UNKNOWN. ITEM#: 180561, COMP NLK SCR 3.5HEX 4.75X35 ST; LOT#: UNKNOWN. ITEM#: 115316, COMP RVRS SHLDR GLNSP +6 36MM; LOT#: UNKNOWN. ITEM#: 00-4349-010-17, TM REVERSE STEM 10MM X 170MM; LOT#: UNKNOWN. ITEM#: 00-4349-036-00, 36MM POLY LINER PLUS 0MM OFS; LOT#: UNKNOWN. G2: FOREIGN: FRANCE. 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.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY WITH NON-ZIMMER BIOMET PRODUCTS ON AND UNKNOWN DATE. THE PATIENT THEN UNDERWENT A REVISION SURGERY APPROXIMATELY ONE (1) YEAR AGO DUE TO AN UNKNOWN REASON. SUBSEQUENTLY, SEVERAL MONTHS AFTER THE REVISION SURGERY, THERE APPEARED TO BE LOOSENING OF THE GLENOID IMPLANTS. THE PATIENT WILL UNDERGO A REVISION SURGERY ON AN UNKNOWN DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 16632 | COMP NLK SCR 3.5HEX 4.75X25 ST | SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES | PHX | ZIMMER BIOMET, INC. | 66127676 | 00880304555402 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other |