MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/RIGHT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Model Number 02.124.414

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Patient height reported as 5 feet 5 inches.Date of event: unknown date in 2018.Additional product code: hrs, hwc.It is unknown if the complainant part is available to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.A review of the device history records has been requested.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 patient underwent removal of a broken variable angle curved condylar plate of the distal femur on an unknown date.The device was originally implanted on (b)(6) 2018.Along with the condylar plate, the six (6) unknown variable angle cannulated locking screw, four (4) unknown variable angle locking screw, and two (2) unknown cortex screws were also removed.It is unknown if there was a surgical delay.Procedure and patient outcome is unknown.Concomitant devices reported: 5.0 variable angle cannulated locking screw (part/lot unknown, quantity 6), 5.0 variable angle locking screw (part/lot unknown, quantity 4), 4.5 cortex screws (part/lot unknown, quantity 2).This report is for a variable angle curved condylar plate.This is report 1 of 1 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.Complainant part is not expected to be returned for manufacturer review/investigation.Part: 02.124.414; lot: 8796174; manufacturing site: mezzovico; release to warehouse date: january 10, 2014.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.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.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

The revision procedure occurred on (b)(6) 2018.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/RIGHT
• 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: 7964903
• MDR Text Key: 123689745
• Report Number: 2939274-2018-54368
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982042897
• UDI-Public: (01)10886982042897
• Combination Product (y/n): N
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.124.414
• Device Catalogue Number: 02.124.414
• Device Lot Number: 8796174
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 70