MAUDE Adverse Event Report: DEPUY SYNTHES, INC. / SYNTHES (USA) LLC 4.5MM VARIABLE ANGLE LCP CURVED CONSULAR PLATE 8 HOLE, LENGTH 195MM; CONDYLAR PLATE FIXATION IMPLANT

Model Number 02.124.408

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 02/04/2019

Event Type  Injury  

Event Description

Surgically implanted medical device broke, (b)(4), synthes, inc.(b)(4), 4.5mm variable angle lcp curved consular plate part # 02.124.408, (b)(4) 8 hole, length 195mm, right 4.5mm va-lcp curved condylar plate page 41, 45 of booklet: depuy synthes drama surgical technique companies of johnson - johnson.(b)(6) is the injured party.Dob (b)(6).She slipped and fell (b)(6) 2018.Broke right femur, just above her artificial knee replacement.Surgery to repair break, added 4.5mm plate, 11 screws; 11 1/2 wks in rehab facility.First 8 weeks - no weight on rt leg.She was finally released to go home with home therapy for month and a half.Started out pt rehab at (b)(6).Two rehab sessions.On (b)(6) while doing her home therapy exercise, horizontal leg lifts, on the 6th lift, she felt something broke, great pain, unable to use her walker.(b)(6), able to get an orthopedic appt with dr (b)(6), xrays were again taken.It showed the implanted plate snapped in half.She was immediately sent over the hosp and admitted on the (b)(6).Because of her blood thinner, she takes for heart disease, surgery was delayed to (b)(6).I requested her orthopedic surgeon, keep, clean up the broken plate.He gave it to me in a sealed envelop.I have possession of the broken plate.My mother at the age of (b)(6) y/o should not have to go through the injury, pain, and suffering from this defective and under engineered design.The break occurred through a non used screw hole.I have plate, photos of xrays through implant, check ups, and finally at break discovery.My name is (b)(6).I am eldest son of (b)(6).I have medical authority for her care.My contact info: (b)(6).My mother's info: (b)(6).(b)(4).

• Brand Name: 4.5MM VARIABLE ANGLE LCP CURVED CONSULAR PLATE 8 HOLE, LENGTH 195MM
• Type of Device: CONDYLAR PLATE FIXATION IMPLANT
• Manufacturer (Section D): DEPUY SYNTHES, INC. / SYNTHES (USA) LLC
• MDR Report Key: 8504133
• MDR Text Key: 141810844
• Report Number: MW5085793
• Device Sequence Number: 0
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 02.124.408
• Device Catalogue Number: 02.124.408
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 87 YR
• Patient Weight: 75