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 2020-01-31 for IBP ULNA RIGHT SM INTLK N/A 114370 manufactured by Biomet Uk Ltd..
[177173635]
(b)(4). Report source: (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a supplemental mdr will be submitted. Concomitant medical products: medical product: ibp hmrl right sm por, catalog #: 114327, lot #: 1131588. Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00059. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[177173636]
It was reported that a patient underwent an initial right elbow arthroplasty due to arthritis. During surgery, the medial nerve was severed. Subsequently, revision surgery was performed due to neurolysis and anastomosis of the median nerve. This surgery is reported to have been unsuccessful. This complaint is reporting the medial nerve lesion after the total elbow prosthesis. This report is based on allegations set forth in patients notice and the allegations there in are unverified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002806535-2020-00060 |
| MDR Report Key | 9652290 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-31 |
| Date of Event | 2010-11-17 |
| Date Mfgr Received | 2019-12-17 |
| Device Manufacturer Date | 2006-05-22 |
| Date Added to Maude | 2020-01-31 |
| 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 | BIOMET UK LTD. |
| Manufacturer Street | WATERTON INDUSTRIAL ESTATES |
| Manufacturer City | BRIDGEND CF313XA |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CF31 3XA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IBP ULNA RIGHT SM INTLK |
| Generic Name | ELBOW PROSTHESIS |
| Product Code | KWI |
| Date Received | 2020-01-31 |
| Model Number | N/A |
| Catalog Number | 114370 |
| Lot Number | 1145890 |
| Device Expiration Date | 2011-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET UK LTD. |
| Manufacturer Address | WATERTON INDUSTRIAL ESTATES BRIDGEND CF313XA UK CF31 3XA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-31 |