MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,health profe report with the FDA on 2020-03-03 for UNK RADIAL HEAD manufactured by Zimmer Biomet, Inc..
[181952330]
(b)(4). Report source: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Product remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[181952331]
It was reported the patient underwent a left elbow arthroplasty. Subsequently, the patient underwent an open capsular release and manipulation of the joint due to stiffness and a loss of range of motion. While under anesthesia, the posterior capsule was released of scar tissue, and the joint was taken through full range of motion. No product was exchanged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2020-00923 |
| MDR Report Key | 9781929 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| Date Received | 2020-03-03 |
| Date of Report | 2020-02-27 |
| Date of Event | 2017-04-07 |
| Date Mfgr Received | 2020-02-10 |
| Date Added to Maude | 2020-03-03 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK RADIAL HEAD |
| Generic Name | ELBOW PROSTHESIS |
| Product Code | KWI |
| Date Received | 2020-03-03 |
| Catalog Number | NI |
| Lot Number | NI |
| 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 | 2020-03-03 |