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 2020-03-31 for UNK GLENOSPHERE NI manufactured by Zimmer Biomet, Inc..
[187370319]
(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 01373. Concomitant medical products: compr srs ic seg - 60mm; part#211225; lot#unk. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[187370320]
It was reported that the patient underwent a comprehensive reverse shoulder construct approximately 4 weeks ago. Two days post-implantation, a dislocation was noticed. Retention screw/set screws were not used. For this patient, no srs stem was used, but the proximal humeral srs component did remain intact. Revision surgery is unknown at this time, but will be updated once it's been scheduled. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2020-01181 |
| MDR Report Key | 9902652 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-07 |
| Date Mfgr Received | 2020-03-10 |
| Date Added to Maude | 2020-03-31 |
| 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 | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK GLENOSPHERE |
| Generic Name | PROSTHESIS, EXTREMITIES |
| Product Code | KWS |
| Date Received | 2020-03-31 |
| Model Number | NI |
| Catalog Number | UNK GLENOSPHERE |
| Lot Number | UNK |
| 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. Other | 2020-03-31 |