FDA Adverse Event Injury Summary report: N

STEM: AMISTEM H HA COATED LAT STEM SIZE 3

MDR report key: 13304092 · Received January 20, 2022

Report

Report Number: 3005180920-2022-00022
Event Type: Injury
Date Received: January 20, 2022
Date of Event: December 21, 2021
Report Date: January 20, 2022
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: LZO
UDI-DI: 07630030804199
PMA / PMN Number: K093944
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

BATCH REVIEW PERFORMED ON 24.12.2021. LOT 133082: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-OCT-2013. EXPIRATION DATE: 2018-08-31. NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 2 SIMILAR REPORTED EVENTS SINCE 2017. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: FEMORAL COMPONENT (STEM AND HEAD) REVISION PERFORMED MORE THAN 7 YEARS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN A YOUNG MAN ((B)(6) AT TIME OF PRIMARY SURGERY). NO INFORMATION CONCERNING PATIENT GENERAL HEALTH STATUS, ACTIVITY LEVEL AND THE PRESENCE OF COMORBIDITIES IS AVAILABLE. IN THE RADIOGRAPHIC IMAGES PROVIDED, RADIOLUCENT LINES AND SIGNS OF STRESS SHIELDING ARE VISIBLE. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY CEMENTLESS HIP ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS FAILURE CANNOT BE DETERMINED.

Description of Event or Problem · 0

REVISION SURGERY WAS PERFORMED 7 YEARS AND 11 MONTHS AFTER THE PRIMARY SURGERY DUE TO STEM MOBILIZATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
70660	STEM: AMISTEM H HA COATED LAT STEM SIZE 3	CEMENTLESS STEM	LZO	MEDACTA INTERNATIONAL SA	01.18.143	133082	07630030804199

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR	Male	Required Intervention