MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 3; HIP CEMENTLESS STEM

Model Number 01.18.133

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Inadequate Osseointegration (2646)

Event Date 03/16/2022

Event Type  Injury  

Event Description

At 11 years and 11 months after the primary, the patient came in reporting pain due to a loose stem and the cause of the loose stem is unknown.The surgeon revised the medacta head and stem with competitor components and revised the medacta liner with a medacta liner.

Manufacturer Narrative

Batch review performed on 11 april 2022: lot 093012: (b)(4 items manufactured and released on 26-feb-2010.Expiration date: 2015-01-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 2018.

• Brand Name: STEM: AMISTEM H HA COATED STD STEM SIZE 3
• Type of Device: HIP CEMENTLESS STEM
• 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: 14072420
• MDR Text Key: 289688932
• Report Number: 3005180920-2022-00255
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804090
• UDI-Public: 07630030804090
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093944
• 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: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Model Number: 01.18.133
• Device Catalogue Number: 01.18.133
• Device Lot Number: 093012
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/26/2010
• 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 Sex: Male