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 2018-05-16 for COMPREHENSIVE REVERSE HUMERAL TRAY STANDARD - TITANIUM 115340 manufactured by Zimmer Biomet, Inc..
[108452917]
(b)(4). Complaint was unable to be confirmed due to limited information received. Product was not returned for evaluation, as the device is still implanted in the patient. Dhr was reviewed and no discrepancies were found. However, investigation results concluded that the reported event was due to design deficiency, as this device is in scope of a previously initiated recall due to the reported issue. 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
[108452918]
It has been reported that patient has been indicated for a reverse shoulder arthroplasty revision approximately eight (8) years post-implantation due to a humeral tray fracture. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-03378 |
| MDR Report Key | 7519746 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-16 |
| Date of Report | 2018-05-15 |
| Date of Event | 2017-10-23 |
| Date Mfgr Received | 2018-04-19 |
| Device Manufacturer Date | 2009-04-06 |
| Date Added to Maude | 2018-05-16 |
| 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 | Z-1103-2017 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPREHENSIVE REVERSE HUMERAL TRAY STANDARD - TITANIUM |
| Generic Name | PROTHESIS, SHOULDER |
| Product Code | PAO |
| Date Received | 2018-05-16 |
| Model Number | NI |
| Catalog Number | 115340 |
| Lot Number | 848190 |
| ID Number | N/A |
| Device Expiration Date | 2019-04-30 |
| 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 | 113630 | 1. Hospitalization; 2. Required No Informationntervention | 2018-05-16 |