MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAILS: FEMORAL; ROD, FIXATION, INTRAMEDULLARY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Calcium Deposits/Calcification (1758); No Code Available (3191)

Event Date 02/22/2018

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown nail.Part and lot numbers are unknown; udi number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.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.(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.

Event Description

This report is being filed after the review of the following journal article: kent wt, shelton tj, eastman j (2018), heterotopic ossification around the knee after tibial nailing and ipsilateral antegrade and retrograde femoral nailing in the treatment of floating knee injuries, international orthopaedics, volume 42, page 1379-1385 (usa).The purposes of this study were to look at: (1) the prevalence and location of heterotopic ossification (ho) around the knee, (2) the severity of ho around the knee in patients treated with intramedullary tibial nailing and ipsilateral antegrade or ipsilateral retrograde femoral nailing in patients with floating knee injuries, and (3) the correlation between severity of ho around the knee and knee rom.From january 1, 2004, to december 31, 2014, 25 patients (26 floating knees) who were treated with intramedullary nailing of their tibia and ipsilateral antegrade femoral intramedullary nailing or ipsilateral retrograde femoral nailing were included in the study.7 patients (5 males and 2 females, mean age 20 +/- 3 years) underwent antegrade femoral nailing and tibial nailing.Meanwhile, 18 patients with 19 floating knees (15 males and 4 females, mean age 27+/-11 years) underwent retrograde femoral nailing and antegrade tibial nailing.All patients were treated with either an unknown synthes femoral intramedullary nail and unknown synthes tibial intramedullary nail or a competitor¿s device.Post-operative knee radiographs from the patient¿s last clinic visit were evaluated for the presence and location of heterotopic ossification (ho) around the knee after intramedullary nailing of femoral shaft and tibial shaft fractures.Knee range of motion (rom) was recorded from the patient¿s last follow-up appointment.The length of follow-up was 509+/-610 days.Complications were reported as follows.(retrograde group) a total of 17 patients had heterotopic ossification.14 patients had heterotopic ossification patellar tendon.3 patients had heterotopic ossification in the quadriceps tendon.4 patients had heterotopic ossification of the medial collateral ligament.1 patient had heterotopic ossification of the lateral collateral ligament.2 patients had heterotopic ossification of the proximal fibula.1 patient had grade iv heterotopic ossification.(antegrade group) a total of 3 patients had heterotopic ossification.2 patients had heterotopic ossification in the patellar tendon.1 patient had heterotopic ossification in the proximal fibula.This report is for the unknown synthes femoral intramedullary nail and unknown synthes tibial intramedullary nail.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.A1, a2, a3, a4: 7 patients (5 males and 2 females, mean age 20 +/- 3 years) underwent antegrade femoral nailing and tibial nailing.Meanwhile, 18 patients with 19 floating knees (15 males and 4 females, mean age 27+/-11 years) underwent retrograde femoral nailing and antegrade tibial nailing.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.

• Brand Name: UNK - NAILS: FEMORAL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9750323
• MDR Text Key: 191445151
• Report Number: 2939274-2020-01035
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention