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 2018-08-07 for COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING 44MM N/A 115340 manufactured by Zimmer Biomet, Inc..
[116364632]
(b)(4). Concomitant medical products: 113647 comp primary stem 7mm std 553200, xl-115363 arcom xl 44-36 std hmrl brng 019320, 115310 comp rvrs shldr glnsp std 36mm 242610, 180511 comp non-lckng screw 4. 75x35mm 288050, 115330 comp rvrs shdr glen bsplt +ha 177750, 118001 versa-dial/comp ti std taper 685290, 115383 comp rvs cntrl scr 6. 5x35mm st 245440, 180504 comp locking screw 4. 75x35mm 436280, 180511 comp non-lckng screw 4. 75x35mm 852740. The investigation is in progress. Once the investigation is completed a follow up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[116364633]
It was reported the patient underwent a reverse total shoulder arthroplasty revision due to pain and a humeral tray fracture, approximately seven (7) years post primary surgery. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-06136 |
| MDR Report Key | 7758329 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-08-07 |
| Date of Report | 2019-01-16 |
| Date of Event | 2016-12-01 |
| Date Mfgr Received | 2019-01-10 |
| Device Manufacturer Date | 2009-10-19 |
| Date Added to Maude | 2018-08-07 |
| 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 | Z-1103-2017 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING 44MM |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | PAO |
| Date Received | 2018-08-07 |
| Model Number | N/A |
| Catalog Number | 115340 |
| Lot Number | 257020 |
| Device Expiration Date | 2019-10-31 |
| 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 | 2018-08-07 |