ARCOM XL 44-36 STD HMRL BRNG
Report
- Report Number
- 0001825034-2022-00425
- Event Type
- Injury
- Date Received
- March 1, 2022
- Date of Event
- March 24, 2021
- Report Date
- June 9, 2022
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- PHX
- UDI-DI
- 00880304475427
- PMA / PMN Number
- K193373
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT IS GETTING PATHOLOGY TESTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MIR WILL BE SUBMITTED. 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. DEVICE PRODUCT CODE : PHX. CONCOMITANT PRODUCTS: PART# 115370, LOT 944340; PART# PT-113950; LOT# 682270; PART# 113648; LOT# 647510; PART# 118001; LOT# 384530; PART# 115310; LOT# 042090; PART# 180560; LOT# 114970; PART# 180558; LOT# 330140; PART# 180553; LOT# 687720; PART# 180553; LOT# 093880; PART# 115398; LOT# 714870; PART# 115330; LOT# 157840; REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2022 - 00424, 0001825034 - 2022 - 00426, 0001825034 - 2022 - 00427, 0001825034 - 2022 - 00428, 0001825034 - 2022 - 00429, 0001825034 - 2022 - 00430, 0001825034 - 2022 - 00431, 0001825034 - 2022 - 00432, 0001825034 - 2022 - 00433, 0001825034 - 2022 - 00434, 0001825034 - 2022 - 00435.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: A4; B4; B5; G3; G6; H1; H2; H3; H6 VISUAL EXAMINATION OF THE PROVIDED PHOTOGRAPHS IDENTIFIED THAT THE BEARING IS WORN. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: LARGE LUCENCY NOTED IN THE GLENOID, LIKELY INDICATING MULTIPLE POSSIBILITIES, INCLUDING METALLOSIS. ADDITIONALLY, THERE ARE SECONDARY FINDINGS THAT COULD BE RELATED TO POLYETHYLENE WEAR INCLUDING POSSIBLE METAL ON METAL CONTACT BETWEEN THE GLENOSPHERE AND THE HUMERAL TRAY. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVERSE SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, IN AN UNKNOWN TIMEFRAME POST-IMPLANTATION, THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING WITH PERIPROSTHETIC OSTEOLYSIS, WEAR OF THE POLY COMPONENT, AND METALLOSIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1303688 | ARCOM XL 44-36 STD HMRL BRNG | PROSTHESIS, SHOULDER | PHX | ZIMMER BIOMET, INC. | N/A | 798550 | 00880304475427 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Female | Required Intervention| H | SEE H10 NARRATIVE |