FDA Adverse Event Injury Summary report: N

OMNIFIT

MDR report key: 4200 · Received July 15, 1992

Report

Report Number: 4200
Event Type: Injury
Date Received: July 15, 1992
Report Date: July 15, 1992
Manufacturer: OSTEONICS CORPORATION C/O VITAL DESIGNS
Product Code: JDG
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

PATIENT VACATIONING IN MEXICO AND WAS REPORTEDLY IN BATHROOM WHEN HE TWISTED AND FELT A SHARP PAIN UN HIS HIP. HE WAS BROUGH TO THIS FACILITY FOR SURGERY WHICH REVEALED A FRACTURE THROUGH THE NECK OF THE IMPLANT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OMNIFIT	TOTAL HIP REPLACEMENT	JDG	OSTEONICS CORPORATION C/O VITAL DESIGNS	1007

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention