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 2017-09-06 for UNKNOWN ULNAR N/A manufactured by Zimmer, Inc..
[84999183]
(b)(6). (b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Patient code(s) - there is no code for revision due to loosening. Therefore, (b)(4) was selected. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2017 - 06286.
Patient Sequence No: 1, Text Type: N, H10
[84999184]
It was reported that the humeral component was revised due to loosening. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
[115597326]
This follow-up report is being submitted to relay additional information. Upon reassessment, it has been determined that this device did not cause or contribute to the reported event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001822565-2017-06287 |
| MDR Report Key | 6845481 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-09-06 |
| Date of Report | 2017-09-29 |
| Date of Event | 2017-07-27 |
| Date Mfgr Received | 2017-09-28 |
| Date Added to Maude | 2017-09-06 |
| 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 | 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, INC. |
| Manufacturer Street | 1800 WEST CENTER STREET |
| Manufacturer City | WARSAW IN 46580 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46580 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN ULNAR |
| Generic Name | PROSTHESIS, EXTREMITY |
| Product Code | KXE |
| Date Received | 2017-09-06 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | 1800 WEST CENTER STREET WARSAW IN 46580 US 46580 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-09-06 |