MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C 01.18.153 CEMENTED STD STEM SIZE 3; HIP CEMENTED STD STEM

Model Number 01.18.153

Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 06/02/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 28 june 2022.Lot 2004828: (b)(4) items manufactured and released on 31-aug-2020.Expiration date: 2025-aug-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Other devices involved: batch review performed on 3 june 2022.Liner: mpact 01.32.3241hct flat pe hc liner ø32/d (k103721) lot 2115598: (b)(4) items manufactured and released on 24-nov-2021.Expiration date: 2026-nov-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Ball heads: mectacer 01.29.204 biolox delta ceramic ball head 12/14 ø 32 size s -4 (k112115) lot 2113859: (b)(4) items manufactured and released on16-dec-2021.Expiration date: 2026-dec-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

Event Description

The patient came in due to a dislocation of the head from the liner and the cause is unknown.About 1 month and a half after the primary surgery, the surgeon revised the stem, and revised the head and liner to dm.Upon distraction of head from liner, the stem appeared loose and was extracted - the cement was not adhered to the stem, thus, the stem pulled out easily.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM C 01.18.153 CEMENTED STD STEM SIZE 3
• Type of Device: HIP CEMENTED STD 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: 14873747
• MDR Text Key: 295029863
• Report Number: 3005180920-2022-00501
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804281
• UDI-Public: 07630030804281
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103189
• 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: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 01.18.153
• Device Catalogue Number: 01.18.153
• Device Lot Number: 2004828
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2020
• 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: Female