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

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

Patient Problems Calcium Deposits/Calcification (1758); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - constructs: tfn/unknown lot.Part and lot numbers are unknown; udi number is unknown.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 as no product was received.The investigation could not be completed and no conclusion could be drawn at the time of filing this report.Product was not returned.Based on the information available, it has been determined that no corrective and 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: singh, s.Et al (2020), surgical management of bilateral hip fractures in a patient with fibro dysplasia ossificans progressive treated with the rar-g agonist palovarotene: a case report, bmc musculoskeletal disorders, vol.21 (204), pages 1-8 (usa).This study presents a case report of a 32-year-old male patient who sustained a left intertrochanteric fracture one year after starting palovarotene.Surgery was performed using a cephalomedullary nail (trochanteric fixation nail, depuy synthes, west chester, pennsylvania).After surgery, he received palovarotene at 20 mg/day for 4 weeks, then 10 mg/day for 8 weeks.Over the subsequent 2 months, the patient showed progressive clinical loss in the range of motion of the left hip and required the use of a cane for ambulation.A review of x-ray images at the time of the fracture showed no evidence of ho at the left hip (fig.2a).Radiologically, ho and a callus were evident around the distal screw by the left knee after 4 months (fig.2b).In addition, ho at the left hip was evident by 9 weeks and fully matured by 14 weeks (fig.2c).Brooker class d ho was clearly present on imaging at 9 months after surgery and matured at 12 months after surgery (fig.2d-e).Nine months after the left hip fracture, the patient had a second fall resulting in a subdural hematoma, left parietal bone fracture, and right intertrochanteric fracture.He underwent intramedullary nailing of the right hip using an identical long cephalomedullary nail, palovarotene 20 mg/day was started at fracture occurrence and continued for 4 weeks, then reduced to 10 mg/day for 8 weeks.Fracture healing was not delayed based on clinical imaging; however, the patient showed continued loss of mobility, requiring the use of a walker and wheelchair.Again, the patient showed multiple and prolonged fop flare-up activity, resulting in a significant increase in the number of flares/years.The right hip showed new development of brooker class b ho at the greater trochanter, near the insertion site of the intramedullary rod, by 3 months after surgery (fig.3).This report is for an unknown synthes tfn constructs.This report is for (1) unk - constructs: tfn.This report is 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: TFN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11423349
• MDR Text Key: 235015618
• Report Number: 2939274-2021-01195
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR