MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48; HIP ACETABULAR SHELL

Catalog Number 01.32.148MB

Device Problem Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 06/29/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 11-jul-2023.Lot 2242559: (b)(4) items manufactured and released on 12-apr-2023.Expiration date: 2028-03-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.

Event Description

At about 5 weeks from the primary, the patient came in reporting pain due to a malpositioned cup and the cause is unknown.The surgeon revised the cup, head, and liner.The surgery was completed successfully.

• Brand Name: CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48
• Type of Device: HIP 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: 17396951
• MDR Text Key: 319802565
• Report Number: 3005180920-2023-00571
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030860959
• UDI-Public: 07630030860959
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143453
• 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: 07/26/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 01.32.148MB
• Device Lot Number: 2242559
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2023
• Initial Date FDA Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/12/2023
• 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 Age: 69 YR
• Patient Sex: Male
• Patient Weight: 82 KG