28MM DIA COCR MOD HD -3MM NK

Report

Report Number: 0001825034-2013-01169
Event Type: Injury
Date Received: April 26, 2013
Date of Event: April 16, 2013
Report Date: March 31, 2013
Manufacturer: BIOMET ORTHOPEDICS
Product Code: JDI
PMA / PMN Number: PK911684
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY EVALUATION RESULTS, WHICH WERE UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. (B)(4) - DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION.

Additional Manufacturer Narrative · 1

EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01168/ 01169).

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE CORRECTED DATE OF INITIAL PROCEDURE AND THE DATE FOR THE REVISION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01168-2 / 01169-2).

Description of Event or Problem · 1

IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO DISLOCATION. THE CUP AND HEAD WERE REMOVED AND REPLACED.

Description of Event or Problem · 1

IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO DISLOCATION. THE OPERATIVE NOTES CONFIRM THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
182589	28MM DIA COCR MOD HD -3MM NK	PROSTHESIS, HIP	JDI	BIOMET ORTHOPEDICS	N/A	927810

Patients

Seq	Age	Sex	Outcome	Treatment
1	82 YR		Hospitalization\| R