FDA Adverse Event Injury Summary report: N

STEM: AMISTEM HA COATED STD SIZE 2

MDR report key: 9494699 · Received December 19, 2019

Report

Report Number: 3005180920-2019-01089
Event Type: Injury
Date Received: December 19, 2019
Date of Event: November 27, 2011
Report Date: December 19, 2019
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: LZO
UDI-DI: 07630030804083
PMA / PMN Number: K093944
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

BATCH REVIEW PERFORMED ON 13 DECEMBER 2019: LOT 102666: 42 ITEMS MANUFACTURED AND RELEASED ON 4-SEP-2010. EXPIRATION DATE: 2015-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 42 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BATCH REVIEWS PERFORMED ON 13 DECEMBER 2019. CUP: VERSAFITCUP 01.26.60MB ACETABULAR SHELL CC Ø 60 LOT. 111942 (K083116) LOT 111942: 20 ITEMS MANUFACTURED AND RELEASED ON 19-JUL-2011. EXPIRATION DATE: 2016-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 19 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BALL HEADS: COCR 01.25.015 COCR BALL HEAD 12/14 Ø 28 SIZE XXL +10.5 (K072857) LOT 072406: 38 ITEMS MANUFACTURED AND RELEASED ON 5-12-2007. EXPIRATION DATE: 2012-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 16 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

Description of Event or Problem · 1

REVISION SURGERY PERFORMED 8 YEARS AND 2 MONTHS AFTER THE PRIMARY DUE TO PAIN AND METALLOSIS. THE SURGEON REVISED THE INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE ORIGIN OF THE METALLOSIS IS UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1288216	STEM: AMISTEM HA COATED STD SIZE 2	UNCEMENTED HIP STEM	LZO	MEDACTA INTERNATIONAL SA		102666	07630030804083

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention