4.5MM VARIABLE ANGLE LCP CURVED CONSULAR PLATE 8 HOLE, LENGTH 195MM 02.124.408

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-10 for 4.5MM VARIABLE ANGLE LCP CURVED CONSULAR PLATE 8 HOLE, LENGTH 195MM 02.124.408 manufactured by Depuy Synthes, Inc. / Synthes (usa) Llc.

Event Text Entries

[141810844] 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).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5085793
MDR Report Key8504133
Date Received2019-04-10
Date of Report2019-04-08
Date of Event2019-02-04
Date Added to Maude2019-04-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Brand Name4.5MM VARIABLE ANGLE LCP CURVED CONSULAR PLATE 8 HOLE, LENGTH 195MM
Generic NameCONDYLAR PLATE FIXATION IMPLANT
Product CodeJDP
Date Received2019-04-10
Model Number02.124.408
Catalog Number02.124.408
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0
ManufacturerDEPUY SYNTHES, INC. / SYNTHES (USA) LLC

Device Sequence Number: 1

Brand Name4.5MM VARIABLE ANGLE LCP CURVED CONSULAR PLATE 8 HOLE, LENGTH 195MM
Generic NameCONDYLAR PLATE FIXATION IMPLANT
Product CodeJDP
Date Received2019-04-10
Model Number02.124.408
Catalog Number02.124.408
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerDEPUYSYNTHES, INC. / SYNTHES (USA) LLC


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2019-04-10

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