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 E1 RETENTIVE +3 MM HUMERAL BEARING N/A EP-115395 manufactured by Zimmer Biomet, Inc..
[117187815]
(b)(4). Concomitant medical products: comprehensive humeral tray 44 mm x 5 mm, [115375; lot 070520]; versa-dial glenosphere standard 36 mm, [115310; lot 247930]; 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]; 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 - 05106, 0001825034 - 2018 - 05163, 0001825034 - 2018 - 05164.
Patient Sequence No: 1, Text Type: N, H10
[117187816]
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 | 0001825034-2018-05107 |
| MDR Report Key | 7785154 |
| 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 | 2016-05-24 |
| 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 E1 RETENTIVE +3 MM HUMERAL BEARING |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | PAO |
| Date Received | 2018-08-15 |
| Model Number | N/A |
| Catalog Number | EP-115395 |
| Lot Number | 253370 |
| 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 |