MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT 3D METAL ACETABULAR SHELL Ø52 TWO-HOLE; MPACT ACETABULAR SHELL

Model Number	01.38.052DH
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	06/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 4 years after the primary, the patient came in reporting pain due to iliopsoas tendonitis and the cause is unknown.The surgeon revised the medacta cup and liner to competitor components and revised the medacta head to a medacta head.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 13-jun-2023: lot 153942: (b)(4) items manufactured and released on 15-jan-2016.Expiration date: 2021-01-02.No anomalies found related to the problem.To date, 46 items of the same lot have been sold with no similar reported case during the period of review.Additional devices involved batch reviews performed on 13-jun-2023: mpact 01.32.3644hct flat pe hc liner ø36/e (k103721) lot 1810220: (b)(4) items manufactured and released on 18-dec-2018.Expiration date: 2023-12-03.No anomalies found related to the problem.To date, 129 items of the same lot have been sold with no similar reported case during the period of review.Ball heads: mectacer 01.29.210 biolox delta ceramic ball head 12/14 ø 36 size l + 4 (k112115) lot 173298: (b)(4) items manufactured and released on 12-sep-2017.Expiration date: 2022-08-31.No anomalies found related to the problem.To date, 145 items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: MPACT 3D METAL ACETABULAR SHELL Ø52 TWO-HOLE
• Common Device Name: MPACT ACETABULAR SHELL
• 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: 17256405
• Report Number: 3005180920-2023-00493
• Device Sequence Number: 20310938
• Product Code: LPH
• UDI-Device Identifier: 07630030812590
• UDI-Public: 07630030812590
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K171966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• 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): 07/04/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/02/2021
• Device Model Number: 01.38.052DH
• Device Catalogue Number: 01.38.052DH
• Device Lot Number: 153942
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2016
• 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: Unknown