FDA Adverse Event Injury Summary report: N

ORTHOPEDIC IMPLANT TIBIA PLATE

MDR report key: 16796192 · Received April 21, 2023

Report

Report Number
MW5116924
Event Type
Injury
Date Received
April 21, 2023
Date of Event
March 10, 2023
Report Date
April 19, 2023
Manufacturer
MERIL INDIA / MERIL HEALTHCARE PVT. LTD.
Product Code
HRS
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
IN
Reporter Occupation
OTHER
Health Professional
*

Narratives

Description of Event or Problem · 0

AS WE (MY COUSIN MR (B)(6) AND MY AUNT MRS (B)(6), WERE HERE AT (B)(6) 2023 WITH INJURY IN RIGHT ANKLE OF MRS (B)(6). PRELIMINARY DIAGNOSE WITH LOWER PROXIMITY FRACTURE OF TIBIA AND FIBULA. AS PER YOUR PRESCRIPTION AND OPINION, SHE UNDERGONE SURGERY FOR REUNION OF TIBULA BY NAILING AND PLATING. IMPLANT WAS SEEN FINE AND INTACT IN POST OPERATIVE XRAY IMAGE ON (B)(6) 2023, (MRS (B)(6) SURGICALS PROVIDED MERIL IMPLANT ). PROGRESSIONS OF PATIENT WAS WONDERFUL UNDER SUPERVISION. WE WERE DONE 3 FOLLOWUP WITH YOU EVERY OCCASION. MEAN WHILE ON DATE OF (B)(6) 2023, PATIENT MRS (B)(6) FEELS SWELLING IN FOOT, MODERATE PAIN AND LITTLE ANGLED WALK. WE IMMEDIATELY APPROACHED YOU AND DONE XRAY AGAIN. FINDING OF XRAY WAS SURPRISING THAT IMPLANT (MERIL MADE) HAS BEEN BROKEN APART AND SEEN LIKE NOT SERVED THE PURPOSE OF SUPPORT THE TREATMENT IN ONLY SHORT TENURE OF APPROX 2.5 MONTH THAT SUPPOSE TO BE INSIDE PATIENT FOR LIFE LONG. SEEMS LIKE UNANTICIPATED ADVERSE DEVICE EFFECT. CURRENT CONDITION OF PATIENT IS VERY SENSITIVE. (B)(6) 55/F. VITALS ARE OK AS OF NOW. ON BED AND ASSISTED MOBILITY SINCE 2.5 MONTH. AS PER CONSULTATION WITH YOU, THAT BROKEN IMPLANT NEEDS TO REMOVE AGAIN AND NEED OF DOING REDO OF PROCEDURE. AFTER THIS OPINION SHARED WITH PATIENT, MRS (B)(6) ANXIOUS AND AGITATED BY HEARING THIS. LOOKING INTO ISSUE OF IMPLANT FAILURE AND PROCEDURE NEEDED TO FIX THIS AGAIN. AND REQUIRE MEDICAL SUPPORT. MERIL, BECAUSE OF THEIR FAULTY PRODUCT, MY PATIENT AND MY FAMILY UNDERGOES IN HARASSMENT AND "AGINE" THROUGH MEDICAL TRAUMA. AS THIS PRODUCTS CLAIMS FOR MEDICAL QUALITY CERTIFICATION AND ENDURANCE OF LONG LIFE CYCLE/ SHELF LIFE. BUT PROVIDED THE SAME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1335980 ORTHOPEDIC IMPLANT TIBIA PLATE PLATE, FIXATION, BONE HRS MERIL INDIA / MERIL HEALTHCARE PVT. LTD.

Patients

Seq Age Sex Outcome Treatment
1 55 YR Female Disability| H| R