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 2018-10-24 for COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING 44MM STD N/A 115340 manufactured by Zimmer Biomet, Inc..
[124801008]
(b)(4). Concomitant medical products: 180503 comp locking screw 4. 75x30mm 447990, 180503 comp locking screw 4. 75x30mm 003080, 180501 comp locking screw 4. 75x20mm 302580, 180500 comp locking screw 4. 75x15mm 655800, 115382 comp rvs cntrl scr 6. 5x30mm st 958100, 118001 versa-dial/comp ti std taper 464500, 115320 comp rvrs shldr glnsp std 41mm 413710, xl-115366 acrom xl 44-41 std hmrl brng 773550, 113636 comp primary stem 16mm mini 420420, 115330 comp rvrs shdr glen bsplt +ha 559110. The complaint is under investigation. Once the investigation is completed a follow up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[124801069]
It was reported that the patient underwent a initial right shoulder arthroplasty and was revised due to implant fracture and pain approximately four (4) years post implantation. No additional information is made available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-09736 |
| MDR Report Key | 7998717 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-10-24 |
| Date of Report | 2019-02-06 |
| Date of Event | 2014-05-21 |
| Date Mfgr Received | 2019-02-01 |
| Device Manufacturer Date | 2010-05-21 |
| Date Added to Maude | 2018-10-24 |
| 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 STD |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | PAO |
| Date Received | 2018-10-24 |
| Model Number | N/A |
| Catalog Number | 115340 |
| Lot Number | 310580 |
| 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 | 2018-10-24 |