MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM BROACH SIZE 5; SURGICAL INSTRUMENT FOR HIP

Catalog Number 01.18.10.105

Device Problems Fracture (1260); Leak/Splash (1354)

Patient Problem Hip Fracture (2349)

Event Date 07/16/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 30 july 2018.Lot 1311249: (b)(4) items manufactured and released on 25 november 2013.No anomalies found related to the problem.To date, this is the first similar event reported on items of the same lot.

Event Description

Revision surgery the same day of primary due to bone fracture, probably happened during broaching.The surgeon performed bone preparation for the amistem-p size 5, as soon as implanted it he noticed the stem was too deep but no fracture was visible using the ct scan.The surgeon then decided to implant a size 6 amistem c cemented, the final implant was too deep as well and ct scan revealed a distal fracture and cement leak.The stem was replaced with another company stem, the fracture was fixed with cables.

Manufacturer Narrative

Investigation performed on 12 september 2018 by quality control manager: from the documentation of lot, don't emerge anomalies; the whole dossier of manufacture is conforming to the specific project.The dimensional control, has not identified any anomaly or production defect.The device are conforming to the specifications of project.Investigation done by r&d product manager on 12 september 2018 dimensional analysis requested on the femoral stem (size 5 std).12 september 2018 dimensional analysis report reveals that no dimensions are outside the drawing specifications.Clinical evaluation performed by medical affairs manager on 12 september 2018 femoral fracture occurred during femoral preparation.Intraoperative femoral fractures are known possible adverse events of total hip replacements, described and quantified in literature.They mainly depend on bone morphology and mechanical properties.In this case, there is no reason to suspect a malfunctioning device.

• Brand Name: AMISTEM BROACH SIZE 5
• Type of Device: SURGICAL INSTRUMENT FOR HIP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7734735
• MDR Text Key: 115540323
• Report Number: 3005180920-2018-00602
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01.18.10.105
• Device Lot Number: 1311249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Date Manufacturer Received: 07/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 108