MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-16 for C/M ELBOW ULNAR N/A 32810505301 manufactured by Zimmer Biomet, Inc..
[100397741]
(b)(4). Multiple mdr reports were filed for this event. Please also see associated report(s): 0001822565 - 2018 - 00973. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[100397742]
It was report the patient was revised to address implant fracture. No further information has been made available at this time.
Patient Sequence No: 1, Text Type: D, B5
[132371497]
This follow-up report is being submitted to relay additional information. Additional:updated corrected device (b)(4). Interchangeable humeral assembly for cemented use only small 62774244 reported event was confirmed by review of x-rays provided. Per the review, "fractured left elbow arthroplasty. Lucencies along the humeral and ulnar components consistent with loosening. Dhr was reviewed and no discrepancies were found. 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
[132371498]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-00974 |
| MDR Report Key | 7278590 |
| Date Received | 2018-02-16 |
| Date of Report | 2018-05-23 |
| Date of Event | 2017-09-20 |
| Date Mfgr Received | 2018-05-18 |
| Device Manufacturer Date | 2014-10-28 |
| Date Added to Maude | 2018-02-16 |
| 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 | C/M ELBOW ULNAR |
| Generic Name | PROSTHESIS, EXTREMITY |
| Product Code | PAE |
| Date Received | 2018-02-16 |
| Model Number | N/A |
| Catalog Number | 32810505301 |
| Lot Number | 62818043 |
| ID Number | N/A |
| Device Expiration Date | 2019-10-31 |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2018-02-16 |