MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: PLATE/SCREWS; PLATE,FIXATION,BONE

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown condylar plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.

Event Description

This report is being filed after the review of the following journal article: bedard j., et al (2020) analysis of the fit of modern pre-contoured distal femur plates: expect an imperfect contour,injury volume 51, pages 719¿722 (usa).This study aims to evaluate whether precontoured modern distal femoral locking plates reliably match the anatomy of patients with native knees and those with tkas.A total of 32 patients were retrospectively reviewed.Two groups were evaluated: 19 patients with radiographically normal knees and those that had undergone tka (21=n).All patients were greater than 18 years of age.Four different distal femoral locking plates were used to measure plate fit.These included zimmer non-contact bridging distal femur plate (zimmer biomet, warsaw, in), smith & nephew 4.5 peri-loc distal femur locking plate (smith & nephew, london, united kingdom), stryker axsos distal femur plate(stryker, kalamazoo, mi), and synthes variable angle locking compression condylar plate (depuy synthes, west chester, pa).Comparison of preoperative to immediate postoperative radiographs evaluated the variable of arthritis and the presence of the tka implant, to see if either one affected plate fit.The following complications were reported as follows: none of the precontoured plates fit the patient¿s anatomy well.This report is for an unknown synthes variable angle locking compression condylar plate.This is report 1 of 1 for (b)(4).A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10649700
• MDR Text Key: 210450734
• Report Number: 2939274-2020-04579
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1