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 2019-03-06 for VERSA-DIAL 42X18X46 HUM HEAD N/A 113032 manufactured by Zimmer Biomet, Inc..
[137993203]
Udi: (b)(4). Concomitant medical products: 115738 compr nano hmrl pps 38mm 696790; 118001 versa-dial/comp ti std taper 170590; 113954 md hybrid glenoid base 4mm 984350; pt-113950 pt hybrid glen post regenerex 066130. Report source- foreign- (b)(6). Investigation is in progress. 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 - 2019 - 00895; 0001825034 - 2019 - 00897; 0001825034 - 2019 - 00900.
Patient Sequence No: 1, Text Type: N, H10
[137993204]
It was reported that the patient had initial shoulder arthroplasty, and subsequently experienced superficial surgical incision infection one month post implantation. The patient was prescribed antibiotics, and the dehiscence was noted to be improving within one month of treatment. No additional information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-00896 |
| MDR Report Key | 8395511 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-06 |
| Date of Report | 2019-05-15 |
| Date of Event | 2019-01-28 |
| Date Mfgr Received | 2019-04-22 |
| Device Manufacturer Date | 2018-05-30 |
| Date Added to Maude | 2019-03-06 |
| 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 | 2019-03-06 |
| Model Number | N/A |
| Catalog Number | 113032 |
| Lot Number | 769260 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Required No Informationntervention | 2019-03-06 |