MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-12-16 for 24MM COCR RADIAL HEAD STANDARD HEIGHT/13.0MM-STERILE 09.402.024S manufactured by Wrights Lane Synthes Usa Products Llc.
[171539553]
Expiration date unknown, lot 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 as no product was received. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. Investigation summary: 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
[171539554]
It was reported that on (b)(6) 2016, the patient underwent a right elbow radial head replacement with depuy synthes radial head prosthesis system. On or about (b)(6) 2018, the patient underwent a removal and replacement of the radial head system due to loosening. This complaint involves two (2) devices. This report is for one (1) 24 mm cocr radial head standard height/13. 0 mm-sterile. This report is 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2019-62685 |
| MDR Report Key | 9477133 |
| Report Source | OTHER |
| Date Received | 2019-12-16 |
| Date of Report | 2019-11-26 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2015-04-07 |
| Date Added to Maude | 2019-12-16 |
| 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 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 24MM COCR RADIAL HEAD STANDARD HEIGHT/13.0MM-STERILE |
| Generic Name | PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER |
| Product Code | KWI |
| Date Received | 2019-12-16 |
| Model Number | 09.402.024S |
| Catalog Number | 09.402.024S |
| Lot Number | 7855835 |
| Device Expiration Date | 2020-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-12-16 |