MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-04 for UNKNOWN HUMERAL STEM N/A manufactured by Zimmer Biomet, Inc..
[119150541]
(b)(4). Patient year of birth: (b)(6). Unique identifier (udi) #: n/a concomitant medical products: 32810509302 - interchangeable ulnar assembly extra small right long 4. 5 inch length - unknown lot; therapy date: unknown. (b)(6). Reported event was confirmed by review of x-rays provided. Review of x-rays notes ossific material adjacent to the proximal ulna medially and anteriorly reflecting prior fracture or heterotopic ossification. There is extensive lucency at the cement-bone interface of essentially the entire humeral component. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 03496.
Patient Sequence No: 1, Text Type: N, H10
[119150542]
It was reported that the patient was indicated for a revision of the right elbow due to patient bone fracture and loosening of implant at an unknown amount of time post implantation. Attempts were made and no additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-04836 |
| MDR Report Key | 7844708 |
| Date Received | 2018-09-04 |
| Date of Report | 2018-09-04 |
| Date Mfgr Received | 2018-08-09 |
| Date Added to Maude | 2018-09-04 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNKNOWN HUMERAL STEM |
| Generic Name | PROSTHESIS, ELBOW |
| Product Code | JDB |
| Date Received | 2018-09-04 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-04 |