MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-05-15 for UNKNOWN COMPREHENSIVE HUMERAL HEAD N/A manufactured by Zimmer Biomet, Inc..
[108256954]
(b)(4). Journal article reference: nelson, clay g. ; brolin, tyler j. ; ford, marcus c. ; smith, richard a. ; azar, frederick m. ; throckmorton, thomas w. (2018). Five-year minimum clinical and radiographic outcomes of total shoulder arthroplasty using a hybrid glenoid component with a central porous titanium post. Journal of shoulder and elbow surgery, 1058-2746/$, pages 1-6. Https://doi. Org/10. 1016/j. Jse. 2018. 01. 012. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as patient died multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-03363, 0001825034-2018-03364, 0001825034-2018-03365. Reported event was unable to be confirmed due to limited information received from the customer. 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. 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. Product location unknown.
Patient Sequence No: 1, Text Type: N, H10
[108256955]
It has been reported in a journal article that six (6) patients who underwent total shoulder arthroplasty's, died on unknown dates after follow-up due to unknown reasons. There was no indication that the cause of death was related to the procedure. It was further relayed that the deaths were not related to the implants. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-03362 |
| MDR Report Key | 7514292 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-15 |
| Date of Report | 2018-05-14 |
| Date Mfgr Received | 2018-04-19 |
| Date Added to Maude | 2018-05-15 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN COMPREHENSIVE HUMERAL HEAD |
| Generic Name | PROTHESIS, SHOULDER |
| Product Code | MJT |
| Date Received | 2018-05-15 |
| 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. Death | 2018-05-15 |