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

Catalog Number	01.13.10.1102R
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	01/21/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: INSTRUMENT FOR HIP SUGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9731955
• Report Number: 3005180920-2020-00072
• Device Sequence Number: 2352520
• Product Code: LXH
• UDI-Device Identifier: 07630040783040
• UDI-Public: 07630040783040
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 01.13.10.1102R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention