AMISTEM C CEMENTED LAT STEM SIZE 3

Report

Report Number: 3005180920-2023-00877
Event Type: Injury
Date Received: November 15, 2023
Date of Event: October 16, 2023
Report Date: November 15, 2023
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: LZO
UDI-DI: 07630030803819
PMA / PMN Number: K103189
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

BATCH REVIEW PERFORMED ON 23-OCT-2023: LOT 130131: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2013. EXPIRATION DATE: 2018-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED ON 8 NOVEMBER 2023 BY MEDACTA MEDICAL MANAGER: REVISION PERFORMED 8 YEARS AND 3 MONTHS AFTER PRIMARY THA, DUE TO STEM LOOSENING. FROM THE RADIOGRAPHIC IMAGE, IT APPEARS THAT THE CEMENT MANTLE ON THE LATERAL SIDE MAY HAVE BECOME DEFICIENT BUT, NOT HAVING PREVIOUS IMAGES, WE CANNOT DETERMINE IF THIS IS A RESULT OF AN EVOLUTIONARY PROCESS OR IF IT WAS THE SITUATION AT POSTOPERATIVE CONTROL. THE ELEVATED ACTIVITY OF THE PATIENT MAY HAVE CONTRIBUTED TO MOBILIZATION STARTING FROM A SITUATION WHERE STEM FIXATION WAS DUBIUS. THE REASON OF THIS FAILURE CANNOT BE DETERMINED BUT THERE IS NO REASON TO SUSPECT A FAULTY DEVICE.

Description of Event or Problem · 0

AT ABOUT 8 YEARS AND 3 MONTHS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF STEM LOOSENING. STEM, BALL HEAD AND LINER HAVE BEEN REVISED SUCCESSFULLY. NOTE: THE SURGEON COMMENTED THAT A POSSIBLE CAUSE OF THE INSUFFICIENT INTEGRATION IN THE CEMENT WAS THE HIGH ACTIVITY OF THE PATIENT SINCE EARLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
319740	AMISTEM C CEMENTED LAT STEM SIZE 3	HIP CEMENTED STEM	LZO	MEDACTA INTERNATIONAL SA		130131	07630030803819

Patients

Seq	Age	Sex	Outcome	Treatment
1	67 YR	Male	Required Intervention