MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2017-10-20 for UNKNOWN COMPREHENSIVE REVERSE SHOULDER N/A manufactured by Zimmer Biomet, Inc..
[89816210]
The product was not returned for evaluation due to unknown location. 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 as the necessary information to adequately investigate the reported event was not provided. Literature: wiater, b. P. , baker, e. A. , salisbury, m. R. , koueiter, d. M. , baker, k. C. , nolan, b. M. , & wiater, m. J. (2015). Elucidating trends in revision reverse total shoulder arthroplasty procedures: a retrieval study evaluating clinical, radiographic, and functional outcomes data. Journal of shoulder and elbow surgery, 24(12), 1915-1925. 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. Zimmer biomet complaint number:(b)(4). This report is being submitted late as it has been identified in remediation.
Patient Sequence No: 1, Text Type: N, H10
[89816211]
Information was received based on review of a journal article entitled, "elucidating trends in revision reverse total shoulder arthroplasty procedures: a retrieval study evaluating clinical, radiographic, and functional outcomes data". The article addresses that three (3) patients required a revision due to hematoma. There has been no further information provided and the patients outcome is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-09303 |
| MDR Report Key | 6964564 |
| Report Source | LITERATURE |
| Date Received | 2017-10-20 |
| Date of Report | 2017-10-19 |
| Date Mfgr Received | 2015-12-09 |
| Date Added to Maude | 2017-10-20 |
| 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 COMPREHENSIVE REVERSE SHOULDER |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | MJT |
| Date Received | 2017-10-20 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | N/A |
| 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. Hospitalization; 2. Required No Informationntervention | 2017-10-20 |