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 2018-07-23 for 4.5MM VA-LCP CURVED CONDYLAR PLATE/18 HOLE/370MM/RIGHT 02.124.418 manufactured by Wrights Lane Synthes Usa Products Llc.
[114694438]
This information is unknown. It is unknown when plate broke. Additional procodes: hrs, hwc. Lot number is unknown. Date of implantation is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Product was not returned and no lot number was provided. Based on the information available, 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
[114694439]
It was reported that on (b)(6) 2018, the patient underwent hardware removal of a variable angle (va) plate, eleven (11) va locking screws, four (4) cortex screws, and one (1) 6. 5 or 7. 3mm cannulated screw. It is not known when the variable angle (va) distal femur plate was implanted. The patient apparently stepped off a curb and the plate broke at the sixth most distal combi-hole due to non-union. Non-union of the mid-shaft and distal femur was confirmed by the surgeon after the entire implant system was removed. Surgeon reported to the sales consultant that it was a non-union rather than the plate's fault. The patient is scheduled for revision to a retrograde nail and distal femur plate on (b)(6) 2018. Explantation surgery was successful. It is unknown if there was a surgical delay. No patient outcome was reported. Concomitant devices: va locking screws (part: unknown, lot: unknown, quantity: 11); cortex screws (part: unknown, lot: unknown, quantity: 4); cannulated screw (part: unknown, lot: unknown, quantity: 1). This report is for a 4. 5mm va-lcp curved condylar plate/18 hole/370mm/right. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-53016 |
| MDR Report Key | 7710128 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-07-23 |
| Date of Report | 2018-07-03 |
| Date Mfgr Received | 2018-07-03 |
| Date Added to Maude | 2018-07-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| 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/18 HOLE/370MM/RIGHT |
| Generic Name | APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR |
| Product Code | JDO |
| Date Received | 2018-07-23 |
| Model Number | 02.124.418 |
| Catalog Number | 02.124.418 |
| 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 | 2018-07-23 |