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

Model Number 01.38.052DH

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Inflammation (1932)

Event Date 06/08/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 318378141
• Report Number: 3005180920-2023-00493
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171966
• 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: 07/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/15/2016
• 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