MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-09-24 for UNKNOWN COMPREHENSIVE SRS PROXIMAL HUMERAL COMPONENT N/A manufactured by Zimmer Biomet, Inc..
[121512379]
(b)(4). Concomitant products: unknown humeral stem; unknown humeral bearing; unknown glenosphere; unknown glenoid baseplate. The complaint is in investigation, once the investigation is completed a follow up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 09097, 0001825034 - 2018 - 09100, 0001825034 - 2018 - 09102, 0001825034 - 2018 - 09103.
Patient Sequence No: 1, Text Type: N, H10
[121512380]
It was reported that patient underwent initial shoulder arthroplasty on unknown date, and a revision surgery has been indicated due to unknown reason. No additional information is made available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-09098 |
| MDR Report Key | 7903080 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-09-24 |
| Date of Report | 2018-12-07 |
| Date Mfgr Received | 2018-12-07 |
| Device Manufacturer Date | 2017-06-19 |
| Date Added to Maude | 2018-09-24 |
| 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 SRS PROXIMAL HUMERAL COMPONENT |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | MJT |
| Date Received | 2018-09-24 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| 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. Other | 2018-09-24 |