MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-11 for UNKNOWN ZIMMER BIGLIANI FLATOW IMPLANT manufactured by Zimmer Inc.
[42375753]
(b)(4). This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[42375754]
It is reported that the patient was revised due to the humeral stem being placed too high superior.
Patient Sequence No: 1, Text Type: D, B5
[52779602]
This information was reported in error on mdr #0001822565-2016-01166-1 on (b)(6) 2016. No device or photos were received; therefore the condition of the component is unknown. Device history records cannot be reviewed since the part and lot number is unknown. This device is used for treatment. Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique. Post operative x-ray from an unknown date was provided for review. Third party review of the x-ray confirms that stem does not appear angulated and no lucency or fracture is seen. It has also been noted in the review that "it does appear that the superior portion of the hardware is positioned at the upper limit of normal to slightly increased (near or above 5 mm) with respect to the greater tuberosity, which raises suspicion that the hardware was not fully delivered into the humerus (presumably from being oversized or resistance to insertion). " product history search cannot be completed since the part and lot number is unknown. Patient's activity level and adherence to rehabilitation protocol is unknown. The investigation could not verify or identify any evidence of product contribution to the reported problem.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2016-01166 |
| MDR Report Key | 5568346 |
| Date Received | 2016-04-11 |
| Date of Report | 2016-03-21 |
| Date of Event | 2016-03-28 |
| Date Mfgr Received | 2016-08-05 |
| Date Added to Maude | 2016-04-11 |
| 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 ZIMMER BIGLIANI FLATOW IMPLANT |
| Generic Name | SHOULDER IMPLANT |
| Product Code | KWR |
| Date Received | 2016-04-11 |
| 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 | 1. Required No Informationntervention | 2016-04-11 |