E1 44-41 RTNV +3 HMRL BRG
Report
- Report Number
- 0001825034-2021-02487
- Event Type
- Injury
- Date Received
- August 24, 2021
- Date of Event
- November 1, 2019
- Report Date
- November 10, 2021
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- KWS
- PMA / PMN Number
- K193373
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(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: 0001825034-2021-02486-3. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE ROOT CAUSE HAS NOT CHANGED FROM THE PREVIOUS INVESTIGATION. 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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-02486-2. D10: MEDICAL PRODUCTS: ITEM#: (B)(6), COMP RVRS SHLDR GLNSP STD 41MM; LOT#: 200500. ITEM#: (B)(6), COMP RVS TRAY CO 44MM; LOT#: 687880. ITEM#: (B)(6), COMP PRIMARY STEM 13MM MICRO; LOT#: 243540. 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.
CMP-(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: UPDATED: B4; B5; G3; G6; H1; H2; H6 CORRECTED: A1 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS; LOT IDENTIFICATION WAS NOT PROVIDED. 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.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
(B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-02486. MEDICAL PRODUCTS: ITEM#: 115320, COMP RVRS SHLDR GLNSP STD 41MM; LOT#: UNKNOWN; ITEM#: 115370, COMP RVS TRAY CO 44MM; LOT#: UNKNOWN; ITEM#: 113613, COMP PRIMARY STEM 13MM MICRO; 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.
IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT SHOULDER REVISION PROCEDURE APPROXIMATELY ONE (1) YEAR AND NINE (9) MONTHS AGO. SUBSEQUENTLY, PATIENT WAS REVISED APPROXIMATELY ONE (1) MONTH AFTER REVISION SURGERY DUE TO THE DISLOCATION OF THE IMPLANTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1259406 | E1 44-41 RTNV +3 HMRL BRG | SHOULDER PROSTHESIS/EXTREMITIES | KWS | ZIMMER BIOMET, INC. | N/A | 189270 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Unknown | Hospitalization| R | SEE H10 NARRATIVE| SEE H10 NARRATIVE |