COMP RVS TRAY CO 44MM
Report
- Report Number
- 0001825034-2023-01269
- Event Type
- Injury
- Date Received
- June 6, 2023
- Date of Event
- May 11, 2023
- Report Date
- December 13, 2023
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- PHX
- UDI-DI
- 00880304543201
- PMA / PMN Number
- K193373
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THE PRODUCT WAS NOT THE DIRECT CAUSE OF THE EVENT. THE INITIAL REPORT SHOULD BE VOIDED.
(B)(4) MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-01268, 0001825034-2023-01270, 0001825034-2023-01271, 0001825034-2023-01272, 0001825034-2023-01273, 0001825034-2023-01274, 0001825034-2023-01283. D10: MEDICAL PRODUCTS: ITEM#: 115310, COMP RVRS SHLDR GLNSP STD 36MM; LOT#: 293460, ITEM#: EP-115393, E1 44-36 STD HMRL BRNG; LOT#: 520070, ITEM#: 115396, COMP RVS CNTRL 6.5X30MM ST/RST; LOT#: 583320, ITEM#: 180550, COMP LK SCR 3.5HEX 4.75X15 ST; LOT#: 365550, ITEM#: 180553, COMP LK SCR 3.5HEX 4.75X30 ST; LOT#: 890170, ITEM#: 180557, COMP NLK SCR 3.5HEX 4.75X15 ST; LOT#: 540130, ITEM#: 010000589, COMP RVRS 25MM BSPLT HA+ADPTR; LOT#: 697110. H3: PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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: 0001825034-2023-01268-1 , 0001825034-2023-01270-1, 0001825034-2023-01271-1, 0001825034-2023-01272-1, 0001825034-2023-01273-1, 0001825034-2023-01274-1, 0001825034-2023-01283-1. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SHOULDER REVERSE TOTAL SHOULDER ARTHROPLASTY APPROXIMATELY SEVEN (7) YEARS AND (B)(6) AGO, SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO METALOSIS OF THE IMPLANTS. THE PATIENT IS SCHEDULED FOR A SECOND REVISION SURGERY IN APPROXIMATELY THREE (3) WEEKS TO IMPLANT CUSTOM IMPLANTS AND COMPLETE THE REVISION.
IT WAS REPORTED A PATIENT HAD A RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE PAIN, MECHANICAL INSTABILITY, AND A CLUNKING SENSATION. RADIOGRAPHIC IMAGING DISPLAYED DISASSOCIATION OF THE IMPLANT AND THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY SEVEN AND HALF YEARS AFTER THE INITIAL SURGERY. DURING THE SURGERY IT WAS FOUND THAT THERE WAS SEVERE METALLOSIS THROUGHOUT THE JOINT AND WEAR TO THE IMPLANT, AND EROSION AND SEVERE OSTEOLYSIS TO THE GLENOID. DUE TO BONE STOCK OF THE GLENOID THE SURGEON PERFORMED THE FIRST STAGE OF A TWO-STAGE REVISION SURGERY. ALL IMPLANTS WERE REVISED EXCEPT FOR THE HUMERAL STEM AS IT WAS WELL FIXED AND A ANTIBIOTIC SPACER WAS PLACED UNTIL THE STAGE TWO REVISION COULD BE COMPLETED. ALL IMPLANTS WERE REVISED EXCEPT THE HUMERAL STEM AS IT WAS WELL FIXED, AND AN ANTIBIOTIC SPACER WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 735949 | COMP RVS TRAY CO 44MM | SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES | PHX | ZIMMER BIOMET, INC. | 115370 | 417500 | 00880304543201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female | Required Intervention| H | SEE H10 NARRATIVE. |