MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2018-02-20 for UNKNOWN ULNA N/A manufactured by Zimmer Biomet, Inc..
[100473850]
(b)(4). This report is being submitted to relay on initial information and investigation results. Reported event was confirmed by x-ray review. X-ray review states fractures of both forearm bones. Given the appearance of the fragments and lack of significant soft tissue swelling regionally, this is believed to be subacute or chronic in nature. Device history record 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.
Patient Sequence No: 1, Text Type: N, H10
[100473851]
The patient underwent the first of a two stage revision due to periprosthetic fracture approximately 4 years post implantation; an elbow prosthesis and intramedullary nail, which had been used to treat a previous ulnar fracture, were removed and the patient is awaiting re-implantation with custom components.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-00995 |
| MDR Report Key | 7283560 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-02-20 |
| Date of Report | 2018-02-19 |
| Date Mfgr Received | 2018-02-06 |
| Date Added to Maude | 2018-02-20 |
| 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 | 3 |
| Brand Name | UNKNOWN ULNA |
| Generic Name | PROSTHESIS, EXTREMITY |
| Product Code | PAE |
| Date Received | 2018-02-20 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | PHYSICIAN |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-02-20 |