MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-12-21 for VERSA-DIAL 50X21X57 HUM HEAD N/A 113053 manufactured by Zimmer Biomet, Inc..
[131205698]
(b)(4). Concomitant medical products: 113632 comp primary stem 12mm mini 411880; 118001 versa-dial/comp ti std taper 367140; 113956 lg hybrid glenoid base 4mm 280600; pt-113950 pt hybrid glen post regenerex 937860. The complaint is under investigation. Once the investigation is completed a follow up report will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-11529.
Patient Sequence No: 1, Text Type: N, H10
[131205699]
It was reported that patient underwent an initial right shoulder surgery, and during the 6 week visit, patient reported pain, instability, and acromioclavicular joint tenderness. During the 3 month visit, patient reported pain, instability, anterior translation, and posterior translation. During the one year visit, patient reported anterior and posterior translation. During the two year visit, patient reported pain, instability, supraspinatus/greater tuberosity tenderness, acromioclavicular joint tenderness, impingement, anterior translation, and posterior translation. It was also reported that the patient experienced inadequate range of motion and rotator cuff tear tendinitis. It was mentioned as a possible procedure related serious injury but no implants related.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-11530 |
| MDR Report Key | 8190450 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-21 |
| Date of Report | 2018-12-21 |
| Date of Event | 2017-06-21 |
| Date Mfgr Received | 2018-11-30 |
| Device Manufacturer Date | 2015-09-03 |
| Date Added to Maude | 2018-12-21 |
| 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 50X21X57 HUM HEAD |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | MBF |
| Date Received | 2018-12-21 |
| Model Number | N/A |
| Catalog Number | 113053 |
| Lot Number | 198190 |
| 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. Other | 2018-12-21 |