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 2018-08-13 for COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE STD 36MM N/A 115310 manufactured by Zimmer Biomet, Inc..
[116997180]
(b)(4). Concomitant product(s): catalog # 113648, comprehensive primary stem 8mm std, lot # 104520; catalog # 118001, versa-dial/comprehensive ti standard taper, lot # 201410; catalog # xl-115363, arcom xl 44-36 standard humeral bearing, lot # 011140; catalog # 115340, comprehensive reverse humeral ti tray 44mm, lot # 492370; catalog # 115330, comprehensive reverse shoulder baseplate, lot # 550050; catalog # 180501, fixed locking screw, lot # 468580. The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Product location unknown.
Patient Sequence No: 1, Text Type: N, H10
[116997181]
It was reported that a patient underwent a right total reverse shoulder arthroplasty. Subsequently, the patient was revised due to dislocation. During the revision it was noted that the patient had signs of metallosis. No further information is currently available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-05021 |
| MDR Report Key | 7779309 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-08-13 |
| Date of Report | 2019-01-17 |
| Date of Event | 2013-06-27 |
| Date Mfgr Received | 2019-01-16 |
| Device Manufacturer Date | 2010-10-06 |
| Date Added to Maude | 2018-08-13 |
| 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 SHOULDER GLENOSPHERE STD 36MM |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | PAO |
| Date Received | 2018-08-13 |
| Model Number | N/A |
| Catalog Number | 115310 |
| Lot Number | 609790 |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-08-13 |