MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-01-16 for UNK - RADIAL HEAD PROSTHESIS manufactured by Wrights Lane Synthes Usa Products Llc.
[175200812]
Reported patient height was 6'3 feet. This report is for an unknown radial head/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/ investigation. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[175200814]
It was reported on (b)(6) 2014, the patient underwent a left radial head replacement and a repair of left lateral ulnar collateral ligament avulsion after he fell about 8 feet off a ladder and suffered an injury to his left elbow on (b)(6) 2014. He had x-rays that showed a comminuted fracture of the radial head with significant displacement. There was no dislocation noted. Patient had patient participated in physical therapy post-operatively. On (b)(6) 2015, the patient fell onto his left elbow and has been having significant pain since that time. On (b)(6) 2019, the patient had a clinic visit for left elbow pain, stiffness and limited range of motion. Patient continues to report pain and limited range of motion. No revision surgery has been planned at this time. This is report 1 of 2 for (b)(4). This report is for an unknown radial head.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-00217 |
| MDR Report Key | 9595644 |
| Report Source | OTHER |
| Date Received | 2020-01-16 |
| Date of Report | 2019-12-18 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-01-16 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK - RADIAL HEAD PROSTHESIS |
| Generic Name | PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER |
| Product Code | KWI |
| Date Received | 2020-01-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-16 |