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
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/02/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3005180920-2022-00501
• Device Sequence Number: 14764774
• Product Code: LZO
• UDI-Device Identifier: 07630030804281
• UDI-Public: 07630030804281
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/23/2025
• Device Model Number: 01.18.153
• Device Catalogue Number: 01.18.153
• Device Lot Number: 2004828
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female