COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING
Report
- Report Number
- 0001825034-2017-02483
- Event Type
- Injury
- Date Received
- April 13, 2017
- Date of Event
- January 3, 2017
- Report Date
- February 7, 2018
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- PAO
- PMA / PMN Number
- PK080642
- Removal / Correction Number
- Z-1103-2017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). THE REPORTED EVENT IS CONFIRMED VIA PHOTOGRAPHS, X-RAYS, AND OPERATIVE NOTES RECEIVED. X-RAY REVIEW SHOWED THAT THE PROSTHESIS WAS DISPLACED AND BROKEN. PHOTOS OF THE TRAY, STEM, AND BEARING IDENTIFIED THAT THE TRAY WAS SCRATCHED, NICKED, AND THE TAPER WAS MISSING. THE STEM WAS SCRATCHED, NICKED, PITTED AND THE TAPER WAS FRACTURED OFF FROM THE TRAY AND REMAINS IN THE STEM. THE BEARING WAS ALSO WORN, DENTED AND HAD FADED MARKINGS. PHOTOS OF DEVICES; TRAY STEM AND BEARING WERE RECEIVED FOR EVALUATION. THE ROOT CAUSE OF THE TRAY FRACTURE IS RELATED TO A PREVIOUSLY ADDRESSED DESIGN DEFICIENCY RELATED TO THE HUMERAL TRAY COMPONENT. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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). UPON REVIEW OF THIS COMPLAINT ON MAR 14, 2017 THE INVOICE WAS PULLED WHICH GIVES US A NEW AWARE DATE FOR THE PRODUCTS THAT HAVE NOT YET BEEN REPORTED. CONCOMITANT MEDICAL DEVICES: COMPREHENSIVE SCREW, CATALOG#:180509, LOT#: 852650; COMPREHENSIVE REVERSE SHOULDER GLENOID BASEPLATE, CATALOG#:115330, LOT#:524560; COMPREHENSIVE REVERSE CENTRAL SCREW, CATALOG#:115383, LOT#: 256750; COMPREHENSIVE NON LOCKING SCREW, CATALOG#:180509, LOT#: 852620; COMPREHENSIVE LOCKING SCREW, CATALOG#:180504, LOT#:029360; COMPREHENSIVE LOCKING SCREW, CATALOG#:180505, LOT#: 852240; COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE, CATALOG#:115310, LOT#:258260; VERSA DIAL TAPER, CATALOG#: 118001, LOT#:927850. CUSTOMER HAS NOT YET INDICATED IF THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE IS PART OF SCOPE FOR PREVIOUSLY ADDRESSED RECALL ZFA 2016-260. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-01423, 0001825034-2017-02483, 0001825034-2017-02487, 0001825034-2017-02489.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
IT IS REPORTED THAT THE PATIENT UNDERWENT RIGHT TOTAL SHOULDER ARTHROPLASTY REVISION APPROXIMATELY SIX (6) YEARS POST-OPERATIVELY DUE TO PAIN, IMPLANT FRACTURE, AND POPPING NOISES IN THE SHOULDER. REVISION OPERATIVE NOTES FURTHER NOTED THICK FIBROTIC CAPSULAR TISSUE, METAL-TINGED FLUID, SMALL PRESENCE OF METALLOSIS, A FRACTURED HUMERAL TRAY IMPLANT WITH THE POST REMAINING IN THE HUMERAL STEM, AND POLYETHYLENE WEAR. THE STEM, TRAY, AND BEARING WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272039 | COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING | PROTHESIS, SHOULDER | PAO | BIOMET ORTHOPEDICS | N/A | 415040 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization| R |