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 2019-01-10 for VERSA-DIAL/COMP TI STD TAPER N/A 118001 manufactured by Zimmer Biomet, Inc..
[132780556]
(b)(4). Multiple mdr's were filed for this event. Please see associated report(s): 0001825034 - 2018 - 11401, 0001825034 - 2018 - 11402, 0001825034 - 2018 - 11403, 0001825034 - 2018 - 11404. (b)(4). Concomitant medical products: 115740 compr nano hmrl pps 40mm lot 820550, 118001 versa-dial/comp ti std taper lot 260450, 113042 versa-dial 46x18x53 hum head lot 060280, 113954 md hybrid glenoid base 4mm lot 268280, pt-113950 pt hybrid glen post regenerex lot 742260. Foreign- the event occurred in (b)(6). As the devices remain implanted; they will not be returned for evaluation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[132780557]
It was reported the patient had a suture abscess that required an irrigation and debridement as well as oral antibiotics; procedure related but not device related, approximately six (6) weeks post-operatively of a total shoulder arthroplasty. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-11401 |
| MDR Report Key | 8237163 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-10 |
| Date of Report | 2019-04-22 |
| Date of Event | 2018-12-03 |
| Date Mfgr Received | 2019-04-18 |
| Device Manufacturer Date | 2018-05-13 |
| Date Added to Maude | 2019-01-10 |
| 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/COMP TI STD TAPER |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | MBF |
| Date Received | 2019-01-10 |
| Model Number | N/A |
| Catalog Number | 118001 |
| Lot Number | 260450 |
| 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 | 2019-01-10 |