MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-06 for UNKNOWN TM REVERSE SHOULDER GLENOSPHERE manufactured by Zimmer Inc.
[35354331]
(b)(4). This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[35354332]
It is reported a patient was implanted with a non-compatible combination of zimmer biomet trabecular metal reverse system and a competitor's components.
Patient Sequence No: 1, Text Type: D, B5
[41643838]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2016-00016 |
| MDR Report Key | 5346630 |
| Date Received | 2016-01-06 |
| Date of Report | 2015-12-09 |
| Date Mfgr Received | 2016-03-21 |
| Date Added to Maude | 2016-01-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KEVIN ESCAPULE |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 8006136131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN TM REVERSE SHOULDER GLENOSPHERE |
| Generic Name | SHOULDER PROSTHESIS |
| Product Code | KWR |
| Date Received | 2016-01-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER INC |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 465810708 US 465810708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-06 |