MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5 VACRVD CONDY PL/18H/370/LT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.419

Device Problem Break (1069)

Patient Problems Bone Fracture(s) (1870); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional device product codes: hrs; hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is legal (attorney).(b)(4).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

It was reported that on (b)(6) 2016, the patient underwent left femur periprosthetic fracture nonunion with revision orif due to left femur fracture in periprosthetic fashion which was treated with open reduction internal fixation (orif) with subsequent nonunion and breakage of the plate.Initially on (b)(6) 2016, the patient tripped over a dog and fell onto the left side.He felt immediate pain on the left hip and noticed a moderate amount of blood with injury and denies loss of consciousness.He was taken to a local hospital for evaluation, where he was found to have an open left femur periprosthetic fracture.His fractured was irrigated and he started on prophylactic antibiotics with ampicillin-sulbactam.He was managed conservatively and was transferred to hospital for special surgery for further management.His pain is well tolerated, and he has no other issues.On (b)(6) 2016, the patient underwent a left femur open reduction internal fixation (orif) and incision & drainage of open wound.On (b)(6) 2016, the patient presented fracture of the left leg.He returned to weight-bearing as tolerated and was doing well with therapy until he noted an increase in instability in the thigh worsening over the past several days.He's been unable to weight-bear through the leg.There is been no issue with infection in the postsurgical period.He has no motor or sensory loss to the extremity.He has no other orthopedic complaints.Patient will require revision orif of the left extremity with potential autografting and double plating.On (b)(6) 2016, patient is 2 weeks s/p left femur periprosthetic fracture nonunion with revision orif.He is very happy with progress, stating is weaning himself from oral pain medication.He continues to progress with in-home therapy and has remained adherent to our nonweight-bearing protocol in the left lower extremity.He denies any new orthopedic complaints.He denies chest pain, shortness breath, fevers, or chills.On (b)(6) 2017, the patient is doing well s/p revision of open reduction internal fixation femoral shaft fracture.Pain is resolved.There are no issues with the wound.He is pleased with his recovery so far.He has noted some occasional discomfort about the femur and comes in for a check-up to ensure no issues with the surgical site.This report is for one (1) 4.5 va curved condylar plate/18h/370/lt.This is report 1 of 1 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.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.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: b6, h6 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.

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.H10 additional narrative: h6: photo investigation: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device image.Visual analysis of the provided patient radiographs revealed that there was a plate and screw construct implanted in the left femur with signs of bone fracture.The va-lcp condylar plate 4.5/5.0 le 18ho l3 is broken in two fragments and were observed in the visual evidence provided.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for va-lcp condylar plate 4.5/5.0 le 18ho l3.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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: 4.5 VACRVD CONDY PL/18H/370/LT
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• 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: 9622941
• MDR Text Key: 189596451
• Report Number: 2939274-2020-00376
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 07611819454156
• UDI-Public: (01)07611819454156
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male