N
Patient 1
(B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
MAUDE MDR 5346630
- MDR report key
- 5346630
- Report number
- 1822565-2016-00016
- Event key
- 0
- Event type
- 3
- Date received
- 2016-01-06
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- KEVIN ESCAPULE
- Address
- P.O. BOX 708 WARSAW IN 46581 US
- Phone
- 800-800-8006
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN TM REVERSE SHOULDER GLENOSPHERE | SHOULDER PROSTHESIS | ZIMMER INC | KWR | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-01-06 | 0 |
Event Narratives#
D
Patient 1
IT IS REPORTED A PATIENT WAS IMPLANTED WITH A NON-COMPATIBLE COMBINATION OF ZIMMER BIOMET TRABECULAR METAL REVERSE SYSTEM AND A COMPETITOR'S COMPONENTS.
N
Patient 1
CONCOMITANT MEDICAL PRODUCTS: CATALOG#UNK, UNKNOWN TM REVERSE SHOULDER BASE PLATE, LOT #UNK. OPERATIVE NOTES WERE REQUESTED HOWEVER NONE PROVIDED. RELEVANT MEDICAL HISTORY AND ADHERENCE TO REHABILITATION PROTOCOL ARE UNKNOWN. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. THE PART AND LOT NUMBERS OF THE PRODUCT ARE UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THESE PRODUCTS WERE USED FOR TREATMENT. THE COMPLAINT HISTORY FOR THESE PRODUCTS COULD NOT BE REVIEWED DUE TO THE LACK OF LOT NUMBERS. ZIMMER-(B)(4) HAS NOT CONFIRMED THE COMPATIBILITY OF THIS COMBINATION OF DEVICES, AND THIS WOULD BE CONSIDERED AN OFF-LABEL USE OF THIS PRODUCT AS INDICATED ON THE PACKAGING INSERT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER (B)(4) CONSIDERS THE INVESTIGATION CLOSED.