FDA Adverse Event Injury Summary report: N

MINIMAX RIGHT ANATOMICAL BROACH SIZE 2

MDR report key: 9731955 · Received February 20, 2020

Report

Report Number: 3005180920-2020-00072
Event Type: Injury
Date Received: February 20, 2020
Date of Event: January 21, 2020
Report Date: February 20, 2020
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: LXH
UDI-DI: 07630040783040
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

NO DOCUMENT REVIEW CAN BE PERFORMED SINCE THE LOT NUMBER IS NOT AVAILABLE. OTHER ANALYIS ARE NOT POSSIBLE AS WELL SINCE WE DID NOT RECEIVED THE DEVICE AND XRAYS. IMPLANT INVOLVED: STEM: MINIMAX 01.13.102R CEMENTLESS ANATOMICAL STEM RIGHT SIZE 2 (K170845) LOT. 132936B VISUAL INSPECTION PERFORMED ON FEBRUARY 20 BY R&D PROJECT MANAGER BASED ON THE DEVICE RECEIVED, WE CAN STATE THAT THE STEM DOES NOT SHOW ANY SIGN OR NON-CONFORMITY. SOME REMOVAL SCRATCHES ARE VISIBLE BUT CAUSED BY THE EXTRACTION OF THE STEM. SINCE ONLY THE STEM WAS SENT AND NOT THE BROACH, NO CONCLUSION CAN BE DRAWN FROM THE ANALYSIS CARRIED OUT. A MORE DETAILED ANALYSIS COULD HAVE BEEN CARRIED OUT IN CASE OF BROACH AVAILABILITY.

Description of Event or Problem · 1

AFTER THE SURGERY, THE PATIENT HAD PAIN AND SWELLING, SO THE SURGEON CHECKED AND DISCOVERED THAT THE DISTAL PART OF THE STEM PERFORATED THE FEMORAL AT X-RAY. THE SURGEON PERFORMED THE REVISION SURGERY IMMEDIATELY AND REPLACED WITH THE MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT # 3. DUE TO THIS EVENT, THE SURGERY WAS PROLONGED ABOUT 1 HOUR. THE TOTAL SURGERY TIME WAS 2 HOURS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
198033	MINIMAX RIGHT ANATOMICAL BROACH SIZE 2	INSTRUMENT FOR HIP SUGERY	LXH	MEDACTA INTERNATIONAL SA			07630040783040

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention