MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2020-01-30 for 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/RIGHT 02.124.408 manufactured by Wrights Lane Synthes Usa Products Llc.
[182748232]
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
[182748415]
It was reported that on (b)(6) 2018, the patient slipped on the tile at her home and fell to the side. The patient suffered a right femur fracture per imaging. On (b)(6) 2018, the patient underwent orif of a right periprosthetic femur fracture. Postoperatively, 2-1/2 weeks later, the patient complained of burning and swelling around the right knee and towards the right lower extremity. On (b)(6) 2018, the patient felt something break at her previous surgical site. A right distal femur periprosthetic fracture occurred. On (b)(6) 2018, the patient complained of left leg pain after exercise which was found to be fractured hardware on (b)(6) 2019. Due to ailed total knee arthroplasty, she was admitted for a procedure because of pain and the risk to the leg with femoral fracture and loose metal. She underwent revision of right total knee arthroplasty, hardware removal on the right femur on the same day. This report is for one (1) 4. 5 mm va-lcp curved condylar plate/ 8 hole/ 195mm/ right. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-00542 |
| MDR Report Key | 9647023 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-03 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2020-01-30 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/RIGHT |
| Generic Name | CONDYLAR PLATE FIXATION IMPLANT |
| Product Code | JDP |
| Date Received | 2020-01-30 |
| Catalog Number | 02.124.408 |
| 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 | 2020-01-30 |