MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: STEM COLLARED HA COATED STD STEM SIZE 3; HIP FEMORAL STEM

Catalog Number 01.18.233

Device Problem Failure to Osseointegrate (1863)

Patient Problem Inadequate Osseointegration (2646)

Event Date 02/26/2024

Event Type  Injury  

Event Description

At 8 years and 2 months from the primary, the patient came in reporting pain due to a distally potted stem and the cause is unknown.The surgeon revised the stem, head, and liner.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 04 march 2024.Lot 153992: (b)(4) items manufactured and released on 07-oct-2015.Expiration date: 2020-09-16.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: STEM: STEM COLLARED HA COATED STD STEM SIZE 3
• Type of Device: HIP 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: 18984914
• MDR Text Key: 338659574
• Report Number: 3005180920-2024-00143
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804588
• UDI-Public: 07630030804588
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121011
• 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: 03/27/2024

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 Expiration Date: 09/16/2020
• Device Catalogue Number: 01.18.233
• Device Lot Number: 153992
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2015
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 64 KG