MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-25 for 4.5MM LCP PROXIMAL FEMUR HOOK PLATE 10 HOLES/277MM 242.124 manufactured by Wrights Lane Synthes Usa Products Llc.
[186095153]
The investigation could not be completed; no conclusion could be drawn, as no product was received. (b)(4). 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
[186095174]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient was treated for a broken femur with im nails twice and the nails broke both times. The patient was treated on (b)(6) 2020 with a fibula allograft down the canal of the femur and the proximal femur hook plate. The femur had lost length, so when regaining length there was a gap at the fracture site where the fibula allograft and plate would be sharing load. At some point after the patient began weight-bearing, the fibula allograft failed causing the plate to bear the load, which lead to a fatigue failure of the plate. On (b)(6) 2020 the patient underwent surgery to have the broken plate removed and the fixation revised. The surgeon replaced the broken plate and added a femoral shaft allograft on the medial side of the patient's femur. Screws were placed through the plate across the femur and through the allograft splint to provide load-sharing and stability on both side of the fracture. No further information provided. Concomitant device reported: unknown screws (part # unknown, lot # unknown, quantity # 9). This report is for one (1) 4. 5mm lcp proximal femur hook plate 10 holes/ 277mm. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01515 |
| MDR Report Key | 9879024 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2016-10-24 |
| Date Added to Maude | 2020-03-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ELMIRA |
| Manufacturer Street | 35 AIRPORT ROAD |
| Manufacturer City | HORSEHEADS NY 14845 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14845 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4.5MM LCP PROXIMAL FEMUR HOOK PLATE 10 HOLES/277MM |
| Generic Name | PLATE, FIXATION, BONE |
| Product Code | HRS |
| Date Received | 2020-03-25 |
| Model Number | 242.124 |
| Catalog Number | 242.124 |
| Lot Number | H217281 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-25 |