MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-22 for ULNAR COMPONENT N/A manufactured by Zimmer Biomet, Inc..
[100922721]
Cmp-(b)(4). Multiple mdr reports were filed for this event. Please also see associated report(s): 0001822565-2018-00919. Report source: literature: barco, r. , streubel, p. N. , morrey, b. F. , & sanchez-sotelo, j. (2017). Total elbow arthroplasty for distal humeral fractures. The journal of bone and joint surgery, 99(18), 1524-1531. Doi:10. 2106/jbjs. 16. 01222. Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown. 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. 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. Device remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[100922722]
It was reported in the journal article that five elbows exhibited bushing wear. No further information has been made available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-00918 |
| MDR Report Key | 7290661 |
| Date Received | 2018-02-22 |
| Date of Report | 2018-03-02 |
| Date of Event | 2017-09-20 |
| Date Mfgr Received | 2018-03-01 |
| Date Added to Maude | 2018-02-22 |
| 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 | ULNAR COMPONENT |
| Generic Name | PROSTHESIS, EXTREMITY |
| Product Code | KXE |
| Date Received | 2018-02-22 |
| 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 | 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 | 2018-02-22 |