MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-31 for VERSA-DIAL 42X18X46 HUM HEAD N/A 113032 manufactured by Zimmer Biomet, Inc..
[146622865]
(b)(4). Concomitant medical products: 115732,comprehensive nano humeral component pps,410710, 113952,modular hybrid glenoid base, 932710, pt-113950,modular hybrid glenoid post? Regenerex, 573810, 118001, comprehensive standard taper adaptor, 076840. Report source: (b)(6). Complaint sample was evaluated and the reported event was not confirmed. As per the operative records and x-rays provided, the rotator cuff was normal. Humeral head had normal contour and the glenoid was normal. There were no complications, deviations from surgical technique, or delays in the procedure. As per the x-ray review of 6-months post initial surgery, no glenoid and humeral radiolucency, subsidence, osteolysis, migration, integrity is intact and no bone fracture. Dhr was reviewed and no discrepancies were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 02385, 0001825034 - 2019 - 02386, 0001825034 - 2019 - 02388. This product was previously reported under mfr 0001825034 - 2018 - 10770.
Patient Sequence No: 1, Text Type: N, H10
[146622866]
It has been reported that patient had initial comprehensive shoulder arthroplasty. Subsequently, six (6) months post initial surgery patient suffered from patient suffered shoulder pain, instability, tenderness, decrease in adls and impingement. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-02389 |
| MDR Report Key | 8657758 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-31 |
| Date of Report | 2019-09-11 |
| Date of Event | 2018-07-03 |
| Date Mfgr Received | 2019-08-26 |
| Device Manufacturer Date | 2016-07-16 |
| Date Added to Maude | 2019-05-31 |
| 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 | VERSA-DIAL 42X18X46 HUM HEAD |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | MBF |
| Date Received | 2019-05-31 |
| Model Number | N/A |
| Catalog Number | 113032 |
| Lot Number | 842820 |
| 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 | 2019-05-31 |