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 2020-01-13 for 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE 04.402.008S manufactured by Wrights Lane Synthes Usa Products Llc.
[186303928]
Complainant part is not expected to be returned for manufacturer review/investigation. Initial reporter is attorney (b)(4). 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
[186303929]
It was reported that on (b)(6) 2019, the patient underwent a revision of right radial head replacement due to loosening of radial stem. On an unknown date, a patient sustained a fall on his outstretched right upper extremity while painting from a ladder and presented with a severe injury to the right upper extremity as noted. Given the nature of the injury, he was seen urgently in the emergency room and urgent surgery was done for best functional outcome. Preoperatively, patient had some numbness in the ulnar nerve distribution, which was likely traction type injury secondary to trauma. On (b)(6) 2015, the patient underwent a right elbow radial head replacement, coronoid/lcl repair, orif of radial styloid fracture, crpp of small finger/ringer p1 base fracture, pinning of multiple carpal bones/fourth to fifth cmc. Over the course of four years, the patient has been doing well with occasional elbow pain with activity, but with improvements in pain while going well with occasional therapy. On (b)(6) 2019, the patient visited the clinic for right elbow pain. Right elbow ct done on (b)(6). On (b)(6) 2019, the patient had a follow-up check-up and reports pain radiating from elbow to the dorsal forearm. He reports pain especially with heavy activity but denies pain at rest. This report is for one (1) 8mm ti straight radial stem 28mm-sterile. This is report 2 of 2 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-00163 |
| MDR Report Key | 9583046 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-13 |
| Date of Report | 2019-12-18 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2014-11-07 |
| Date Added to Maude | 2020-01-13 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1124-2017 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE |
| Generic Name | PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER |
| Product Code | KWI |
| Date Received | 2020-01-13 |
| Model Number | 04.402.008S |
| Catalog Number | 04.402.008S |
| Lot Number | 7640883 |
| Device Expiration Date | 2019-09-01 |
| 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 | 2020-01-13 |