FDA Adverse Event Injury Summary report: N

AMISTEM H HA COATED STD STEM SIZE6

MDR report key: 7306125 · Received March 1, 2018

Report

Report Number: 3005180920-2018-00102
Event Type: Injury
Date Received: March 1, 2018
Date of Event: January 30, 2018
Report Date: March 1, 2018
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: LZO
UDI-DI: 07630030804120
PMA / PMN Number: K093944
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS ON 16 FEBRUARY 2018: HIP REVISION SURGERY OCCURRED 5,5 YEARS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY. RADIOGRAPHIC IMAGE PROVIDED SHOWS THE PRESENCE OF A MOBILIZED STEM. ASEPTIC LOOSENING IS A POSSIBLE, LITERATURE DESCRIBED ADVERSE EVENT AFTER CEMENTLESS THA AND CAUSES ARE OFTEN UNKNOWN. IN THIS CASE, REASON OF FAILURE CANNOT BE DETERMINED. BATCH REVIEW PERFORMED ON 26 FEBRUARY 2018 LOT 120924: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 JUNE 2012. EXPIRATION DATE: 2017-05-31 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 INSTABILITY 5 YEARS AND 5 MONTHS AFTER PRIMARY. THE CAUSE IS UNKNOWN. THE STEM CAME OUT VERY EASILY, TOOK NO TIME WITH THE MEDACTA STEM EXTRACTOR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
151433	AMISTEM H HA COATED STD STEM SIZE6	CEMENTLESS HIP STEM	LZO	MEDACTA INTERNATIONAL SA		120924	07630030804120

Patients

Seq	Age	Sex	Outcome	Treatment
1	49 YR		Required Intervention