MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MINIMAX RIGHT ANATOMICAL BROACH SIZE 2; INSTRUMENT FOR HIP SUGERY

Catalog Number 01.13.10.1102R

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hip Fracture (2349)

Event Date 01/21/2020

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: MINIMAX RIGHT ANATOMICAL BROACH SIZE 2
• Type of Device: INSTRUMENT FOR HIP SUGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 9731955
• MDR Text Key: 188735702
• Report Number: 3005180920-2020-00072
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07630040783040
• UDI-Public: 07630040783040
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01.13.10.1102R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention