MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2018-12-11 for COMPREHENSIVE REVERSE E1 44-36 STD HMRL BRNG N/A EP-115393 manufactured by Zimmer Biomet, Inc..
[130049271]
(b)(4). Foreign - (b)(6). (b)(4). Concomitant medical product: 115340 comp rvs hmrl ti tray 44mm, 252440. The complaint is under investigation. Once the investigation is complete a follow mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-11071.
Patient Sequence No: 1, Text Type: N, H10
[130049272]
It was reported that during a reverse shoulder arthroplasty, the humeral bearing would not seat properly in the humeral tray. New implants were used to complete the surgery. No patient injury or delay in surgery was noted. No additional information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-11070 |
| MDR Report Key | 8151509 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-12-11 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-11-15 |
| Date Mfgr Received | 2018-11-15 |
| Device Manufacturer Date | 2016-11-11 |
| Date Added to Maude | 2018-12-11 |
| 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 | COMPREHENSIVE REVERSE E1 44-36 STD HMRL BRNG |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | PAO |
| Date Received | 2018-12-11 |
| Returned To Mfg | 2019-01-14 |
| Model Number | N/A |
| Catalog Number | EP-115393 |
| Lot Number | 157730 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-12-11 |