MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-08-15 for COMPREHENSIVE REVERSE GLENOSPHERE STANDARD N/A 115310 manufactured by Zimmer Biomet, Inc..
[117187508]
(b)(4). Concomitant medical products: comprehensive humeral tray 44 mm x 5 mm, [115375; lot 070520]; central screw 6. 5 mm 3. 5 hex 30 mm length, [115396; lot 492050]; fixed locking screw 4. 75 mm 3. 5 hex 30 mm length, [180553; lot 642760]; fixed locking screw 4. 75 mm 3. 5 hex 35 mm length, [180554; lot 135720]; e1 retentive +3 mm humeral bearing 44? 36 mm, [ep-115395; lot 253370]; comprehensive mini baseplate and taper adaptor 25 mm, [010000589; lot 082010]; fixed locking screw, [180550; lot 808750]; fixed locking screw, [180550; lot 084440]. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 05107, 0001825034 - 2018 - 05163, 0001825034 - 2018 - 05164.
Patient Sequence No: 1, Text Type: N, H10
[117187509]
It was reported the patient underwent a possible closed reduction procedure of a reverse total shoulder arthroplasty approximately one (1) month post-operatively due to dislocation. Subsequently, the patient underwent a revision procedure approximately two (2) months post-operatively due to humeral stem subsidence/migration. Patient also had comminuted humeral bone that was removed. A larger humeral tray and bearing were also implanted.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 0001825034-2018-05106 |
MDR Report Key | 7785156 |
Report Source | COMPANY REPRESENTATIVE,CONSUM |
Date Received | 2018-08-15 |
Date of Report | 2019-01-11 |
Date of Event | 2016-09-26 |
Date Mfgr Received | 2019-01-09 |
Device Manufacturer Date | 2016-05-20 |
Date Added to Maude | 2018-08-15 |
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 GLENOSPHERE STANDARD |
Generic Name | PROSTHESIS, SHOULDER |
Product Code | PAO |
Date Received | 2018-08-15 |
Model Number | N/A |
Catalog Number | 115310 |
Lot Number | 247930 |
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 | 2018-08-15 |