MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/LEFT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.409

Device Problem Break (1069)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Non-union Bone Fracture (2369); No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional pro-codes: hwc & jdp.Udi & lot 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; no conclusion could be drawn at the time of filing this report.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) 2018 the patient had a non union distal femur , left lower extremity periprosthetic.The patient underwent a take down of a non union and removal of hardware and revision of an orif with infuse bone graft and 40 ml of corticocancellous bone.All bony prominences were well padded and her left lower extremity was prepped and draped in standard surgical fashion with chloraprep.Plate was noted to be broken in two at the fracture site.Procedure was successfully completed with no surgical delay.There was no patient consequences.This complaint involves thirteen (13) devices.The linked complaint (b)(4) for the additional three (3) devices.This report is for one (1) 4.5mm va-lcp curved condylar plate/ 8 hole/ 195mm/ left.This report is 9 of 10 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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 synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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: b5 d6 d7 h6: code 3191 used to capture fracture nonunion, surgical intervention and medical device removal.H11 corrected data: e1 e2 e3 e4 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

On (b)(6) 2018 the patient had a left femur comminuted distal femur peri-prosthetic fixation and open reduction internal fixation (orif) with bone graft.All bony prominences were well padded and her left lower extremity was prepped and draped in standard surgical fashion with chloraprep.The plate was noted to be broken in two (2) at the fracture site.The procedure was successfully completed with no surgical delay.There was no patient consequences.On (b)(6) 2019 the patient had a revision surgery performed to remove the hardware due to a nonunion.The revision was of an orif with infused bone graft and 40 ml of corticocancellous bone.

Manufacturer Narrative

Product complaint # (b)(4).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.B4: awareness date updated to 06/25/2020.H3, h6: the investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The 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.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/LEFT
• 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
• MDR Report Key: 10076837
• MDR Text Key: 192026277
• Report Number: 2939274-2020-02468
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.409
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 100