MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 95 DEG CONDYLAR PLATE 12 HOLES/80MM/204MM; APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT

Catalog Number 237.26

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

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - plates: distal femur/ unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.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, a synthes distal femur plate construct will be removed and a total knee will be revised on (b)(6) 2021.The diagnosis for the surgery is listed as ¿painful right total knee arthroplasty with retained distal femur plate¿.This report is for one (1) unk - plates: distal femur.This is report 1 of 2 for complaint (b)(4).

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.D2: additional product code: hrs.B5: modified event description.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

Modified event description.It was reported that on (b)(6), 2021, a 95 deg condylar plate 12 holes/80/204, four (4) unk - screws: 4.5 mm cortex, & two (2) unk - screws: 6.5 mm cancellous was removed.The surgeon removed four screws proximally on the shaft and made a cut above to total knee prosthesis to perform a distal femur replacement.The original procedure was performed on (b)(6), 2021.The diagnosis for the surgery is listed as ¿painful right total knee arthroplasty with retained distal femur plate¿.The hardware was removed successfully.The patient outcome is unknown.This complaint involves seven (7) devices.

• Brand Name: 95 DEG CONDYLAR PLATE 12 HOLES/80MM/204MM
• Type of Device: APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11890548
• MDR Text Key: 253755389
• Report Number: 2939274-2021-02622
• Device Sequence Number: 1
• Product Code: KTW
• Combination Product (y/n): N
• PMA/PMN Number: K914546
• 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: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 237.26
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/26/2021
• Supplement Dates Manufacturer Received: 09/03/2021
• Supplement Dates FDA Received: 10/01/2021
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: DISTAL FEMUR.
• Patient Outcome(s): Required Intervention
• Patient Weight: 111