COCR FEMORAL HEAD 32 S

Report

Report Number: 3005180920-2013-00101
Event Type: Injury
Date Received: August 29, 2013
Manufacturer: MEDACTA INTERNATIONAL, SA
Product Code: LZO
PMA / PMN Number: K072857
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DOCUMENT REVIEW: COCR BALL HEAD 32 SIZE S - REF. (B)(4) / LOT 120548 (60 HEADS PRODUCED): ALL PARAMETERS HAVE BEEN FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION CYCLINGS. THE 29 HEADS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. MPACT HC PE LINER 32/D (K103721): REF. (B)(4) / LOT 102199 (11 LINERS PRODUCED): ALL PARAMETERS HAVE BEEN FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION CYCLINGS. ALL THE ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. MPACT SHELL TWO HOLES 48 (K103721): REF. (B)(4) - LOT 092479 (21 CUPS PRODUCED): ALL PARAMETERS HAVE BEEN FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION CYCLINGS. ALL THE ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. MPACT CANCELLOUS BONE SCREW L 25 6, 5 (K103721): REF. (B)(4) - LOT 103026 (100 SCREWS PRODUCED / 53 IMPLANTED): ALL PARAMETERS HAVE BEEN FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE INFECTION IS DEVICE RELATED.

Description of Event or Problem · 1

PLEASE REFER IMPORTER REPORT # (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
427292	COCR FEMORAL HEAD 32 S	METALLIC FEMORAL BALL HEAD	LZO	MEDACTA INTERNATIONAL, SA

Patients

Seq	Age	Sex	Outcome	Treatment
1