FDA Adverse Event Injury Summary report: N

VERSAFITCUP DM ACETABULAR SHELL

MDR report key: 2861814 · Received November 29, 2012

Report

Report Number: 3005180920-2012-00081
Event Type: Injury
Date Received: November 29, 2012
Date of Event: October 2, 2012
Report Date: November 29, 2012
Manufacturer: MEDACTA INTERNATIONAL, SA
Product Code: MEH
PMA / PMN Number: K083116
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

DOCUMENT REVIEW: VERSAFITCUP DOUBLE MOBILITY ACETABULAR SHELL - (B)(4) / LOT 114164 ((B)(4) SHELLS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDED WASHING AND STERILIZATION CYCLES. (B)(4) CUPS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. VERSAFITCUP DOUBLE MOBILITY ACETABULAR SHELL - (B)(4) / LOT 120582 ((B)(4) SHELLS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDED WASHING AND STERILIZATION CYCLES. (B)(4) CUPS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. FROM THE DATA COLLECTED, THE PROBLEM OCCURRED IS HIGHLY LIKELY DUE TO A SURGICAL MISTAKE OR A WRONG SURGICAL PLAN AND NOT DEVICE RELATED.

Description of Event or Problem · 1

A SIZE 50 AND SIZE 54 WERE INSERTED BUT WOULD NOT SEAT PROPERLY AFTER NUMEROUS ATTEMPTS, WITH ADD'L REAMING A SHELL WITH SCREWS WAS USED, THE PT HAD SOFT BONE AND AN UNUSUAL ACETABULAR ANATOMY. WE WERE INFORMED ON (B)(6) 2012 ONLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VERSAFITCUP DM ACETABULAR SHELL	ACETABULAR DOUBLE MOBILITY SHELL	MEH	MEDACTA INTERNATIONAL, SA		114164

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention	SIZE 54 OF THE SAME CUP: (B)(4) - LOT 120582