MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-01-23 for 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/LEFT 02.124.411 manufactured by Wrights Lane Synthes Usa Products Llc.
[176092027]
Additional device product code: hwc; hrs. Complainant part is not expected to be returned for manufacturer review/ investigation. (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
[176092028]
It was reported that on (b)(6) 2017, the patient underwent a revision of distal left femur open reduction and internal fixation with bone grafting and lateral plate and screw fixation for fracture nonunion. Preoperatively, images revealed a displaced distal femur fracture nonunion with broken hardware. The plate was broken. All screws were removed as well as the broken plate. It was found out that there was fibrous union tissue seen within the comminuted area and an attritional bone loss consistent with atrophic areas of nonunion and was implanted with a 4. 5 mm valcp cond plate and a 3. 5 x 32mm self-tap screw. Initially on (b)(6) 2016, the patient underwent an open reduction internal fixation left distal femur fracture due to deformity and pain in the left thigh sustained from a fall while on vacation. X-rays and ct revealed an intra-articular fracture involving the left femur. The patient was implanted with depuy synthes implants. Postoperatively, on (b)(6) 2016, radiographs show a healing fracture post plate and screw osteosynthesis. Interval callus formation is noted with acceptable alignment but still has delayed union. No hardware complications or other acute findings. On (b)(6) 2017, the patient's condition was getting improvement and was able to ambulate w/ assistance of a cane. Unfortunately, he slipped on a wet cement floor and had a fall and injured the left knee. He heard a pop at the knee and since then he had severe pain and has been unable to place weight on his left lower extremity which led to revision procedure on (b)(6) 2017. This report captures first revision performed on (b)(6) 2017 due to broken plate, while related complaint (b)(4) captures the second revision which was performed on (b)(6) 2018 due to non-union. Concomitant device reported: 5. 0mm variable angle locking screw 75mm (part # 02. 231. 275, lot # unknown, quantity 2); 5. 0mm variable angle locking screw 55mm (part # 02. 231. 255, lot # unknown, quantity 1); 5. 0mm variable angle locking screw 80mm (part # 02. 231. 280, lot # unknown, quantity 2); 5. 0mm variable angle locking screw 85mm (part # 02. 231. 285, lot # unknown, quantity 1); 4. 5mm cortex screw self-tapping 40mm (part # 214. 840, lot # unknown, quantity 2); 4. 5mm cortex screw self-tapping 42mm (part # 214. 842, lot # unknown, quantity 1); 4. 5mm cortex screw self-tapping 44mm (part # 214. 844, lot # unknown, quantity 1). This report is for one (1) 4. 5mm va-lcp curved condylar plate/ 10 hole/ 230mm/ left. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-00375 |
| MDR Report Key | 9622773 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-01-23 |
| Date of Report | 2020-01-03 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-01-23 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | WERK MEZZOVICO (CH) |
| Manufacturer Street | VIA CAVAZZ 5 |
| Manufacturer City | MEZZOVICO 6805 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6805 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/LEFT |
| Generic Name | IMPLANT,FIXATION DEVICE, CONDYLAR PLATE |
| Product Code | JDP |
| Date Received | 2020-01-23 |
| Model Number | 02.124.411 |
| Catalog Number | 02.124.411 |
| 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 | 5 | 1. Required No Informationntervention | 2020-01-23 |