FDA Adverse Event Injury Summary report: N

AMISTEM H FEMORAL CEMENTLESS STEM SIZE 6 LAT

MDR report key: 3810223 · Received April 28, 2014

Report

Report Number: 3005180920-2014-00048
Event Type: Injury
Date Received: April 28, 2014
Report Date: April 28, 2014
Manufacturer: MEDACTA INTERNATIONAL, SA
Product Code: LZO
PMA / PMN Number: K093944
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

DOCUMENT REVIEW: AMISTEM H CEMENTLESS FEMORAL STEM SIZE 6 LAT: REF. 01.18.146 / LOT 101026 ((B)(4) STEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. (B)(4) STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. MPACT CUP CEMENTLESS SIZE 52: REF. 01.32.052DH / LOT 092481 ((B)(4)CUPS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. (B)(4) CUPS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. MPACT HC UHMWPE LINER SIZE 52: REF. 01.32.3644HCT / LOT 121151 ((B)(4) LINERS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. (B)(4) LINERS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. FROM THE INFO COLLECTED, THERE ARE NO EVIDENCE THAT THE EVENT IS DEVICE RELATED.

Description of Event or Problem · 1

REF IMP# (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
253722	AMISTEM H FEMORAL CEMENTLESS STEM SIZE 6 LAT	FEMORAL CEMENTLESS STEM	LZO	MEDACTA INTERNATIONAL, SA		101026

Patients

Seq	Age	Sex	Outcome	Treatment
1				SHELL CODE 01.32.052DH, LOT #092481\| LINER CODE 01.32.3644HCT, LOT 121151\| MPACT SHELL AND LINER (K100721):