COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING
Report
- Report Number
- 0001825034-2025-01317
- Event Type
- Injury
- Date Received
- May 5, 2025
- Date of Event
- April 14, 2025
- Report Date
- August 26, 2025
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- PHX
- UDI-DI
- 00880304543201
- PMA / PMN Number
- K113069
- Removal / Correction Number
- NI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). D10: ITEM# 180554; LOT# 533160, ITEM# 180559; LOT# 360740, ITEM# 32-486265; LOT# 818770, ITEM# 32-486265; LOT# 818560, ITEM# 405800; LOT# 687740, ITEM# 405883; LOT# 985660, ITEM# 115397; LOT# 667560, ITEM# 180552; LOT# 096630, ITEM# 115310; LOT# 815700, ITEM# 118001; LOT# 743970, ITEM# 115330; LOT# 790190, ITEM# 180557; LOT# 320880, ITEM# 113654; LOT# 044360, ITEM# EP-115393; LOT# 822020. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; B7; D2; G1; G3; G6; H1; H2; H6. 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 FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6. VISUAL EXAMINATION OF THE PROVIDED PHOTOGRAPH IDENTIFIED THAT THE POST OF THE TRAY HAS FRACTURED AND REMAINS IN THE REVISED STEM. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT WAS NOTED THAT THE PAIN AND POP OCCURRED WHILE THE PATIENT WAS EXERCISING WHICH COULD BE A CONTRIBUTING FACTOR; HOWEVER, WITHOUT ADDITIONAL INFORMATION ON THE TYPE OF EXERCISE OR FORCE EXPERIENCED, A DEFINITIVE STATEMENT CANNOT BE MADE. THE REPORTED EVENT IS CONFIRMED VIA PHOTOGRAPHS. 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 SHOULDER REVISION APPROXIMATELY NINE (9) YEARS AND FIVE (5) MONTHS POST-IMPLANTATION DUE TO EXPERIENCING A HUMERAL TRAY FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER REVISION APPROXIMATELY NINE (9) YEARS AND FIVE (5) MONTHS POST-IMPLANTATION DUE TO EXPERIENCING A FRACTURE OF THE HUMERAL TRAY'S STEM/KNOB. IT WAS NOTED THE PATIENT WAS EXERCISING WHEN THEY HEARD A POP, FOLLOWED BY EXPERIENCING PAIN. IT WAS NOTED BECAUSE THE HUMERAL TRAY'S KNOB WAS FRACTURED OFF INTO THE HUMERAL STEM, THE STEM ALSO HAD TO BE REMOVED, CAUSING THE REVISION TO BE PROLONGED 2 HOURS LONGER THAN ANTICIPATED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1513954 | COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING | SHOULDER PROSTHESIS, REVERSE CONFIGURATION | PHX | ZIMMER BIOMET, INC. | NI | 436370 | 00880304543201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Hospitalization| R | SEE NARRATIVE IN H11. |