FDA Adverse Event Injury Summary report: N

UNKNOWN HIP

MDR report key: 3781001 · Received April 30, 2014

Report

Report Number: 0001825034-2014-03467
Event Type: Injury
Date Received: April 30, 2014
Date of Event: July 14, 1981
Report Date: April 2, 2014
Manufacturer: BIOMET ORTHOPEDICS
Product Code: JDI
PMA / PMN Number: PUNKNOWN
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: PRODUCT IDENTIFICATION/EXPIRY DATE; MANUFACTURE DATE. THIS REPORT IS NUMBER 2 OF 10 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-00557 & 03467 / 03475).

Description of Event or Problem · 1

BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA REGARDING PATIENTS ENROLLED IN A CLINICAL STUDY. IT WAS REPORTED PATIENT UNDERWENT A RIGHT HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2005 DUE TO LOOSENING OF THE CUP. ADDITIONAL INFORMATION RECEIVED IN PATIENT CLINICAL DATA INDICATES THAT THE PATIENT UNDERWENT INITIAL TOTAL HIP ARTHROPLASTY ON (B)(6) 1976 RECEIVING A COMPETITOR HIP SYSTEM. THE FIRST REVISION PROCEDURE OCCURRED ON (B)(6) 1981 WHERE IT IS UNKNOWN WHETHER OR NOT A BIOMET HIP WAS IMPLANTED. SEVERAL OTHER REVISION PROCEDURES TOOK PLACE ON THE FOLLOWING DATES FOR UNKNOWN REASONS: (B)(6) 1981; (B)(6) 1987; (B)(6) 1988; (B)(6) 1992; (B)(6) 1993; (B)(6) 1995; (B)(6) 1998.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
259915	UNKNOWN HIP	PROSTHESIS, HIP	JDI	BIOMET ORTHOPEDICS	N/A	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	49 YR		Hospitalization\| R