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 2020-01-02 for UNKNOWN RADIAL HEAD W/LOCKING SCREW N/A manufactured by Zimmer Biomet, Inc..
[173541926]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted. Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. 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. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[173541927]
It was reported that a patient underwent an explor elbow arthroplasty on an unknown date. Subsequently, the patient is being revised on an unknown date due to the locking screw backing out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-05821 |
| MDR Report Key | 9538492 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-02 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-01-02 |
| 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 | UNKNOWN RADIAL HEAD W/LOCKING SCREW |
| Generic Name | PROSTHESIS ELBOW |
| Product Code | JDB |
| Date Received | 2020-01-02 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| 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 | 2020-01-02 |