FDA Adverse Event Injury Summary report: N

AMISTEM H, HA COATED STEM SIZE 4 STD

MDR report key: 6983014 · Received October 27, 2017

Report

Report Number: 3005180920-2017-00621
Event Type: Injury
Date Received: October 27, 2017
Date of Event: September 14, 2017
Report Date: October 27, 2017
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: LZO
UDI-DI: 07630030804106
PMA / PMN Number: K093944
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

BATCH REVIEWS PERFORMED ON 24 OCTOBER 2017. LOT 166422: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 JANUARY 2017. EXPIRATION DATE: 2022-01-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 54/28, CODE 01.26.2854MHC, LOT. 160253 (K092265) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 APRIL 2016. EXPIRATION DATE: 2021-04-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5, CODE 01.29.203, LOT. 161052 (K112115) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 MAY 2016. EXPIRATION DATE: 2021-04-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

Description of Event or Problem · 1

THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
762378	AMISTEM H, HA COATED STEM SIZE 4 STD	CEMENTLESS FEMORAL STEM	LZO	MEDACTA INTERNATIONAL SA		166422	07630030804106

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention