MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM DETAILS UNKNOWN; FEMORAL STEM

Catalog Number UNKNOWN

Device Problem Failure to Osseointegrate (1863)

Patient Problem Implant Pain (4561)

Event Date 11/27/2023

Event Type  Injury  

Event Description

The patient had pain due to a loose stem, which was caused by osteolysis.The surgeon revised the medacta stem and head with a competitor's products.The liner is unknown.The surgery was completed successfully.The patient's primary surgery took place in belgium in 2013.No additional details are available.

Manufacturer Narrative

Further analysis cannot be performed.

• Brand Name: STEM DETAILS UNKNOWN
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18335160
• MDR Text Key: 330602232
• Report Number: 3005180920-2023-01019
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/15/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Race: White