MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø54 NO-HOLE; ACETABULAR CUP

Catalog Number 01.32.154SH

Device Problem Failure to Osseointegrate (1863)

Patient Problem Inadequate Osseointegration (2646)

Event Date 02/22/2024

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 26 feb 2024 lot 2217482: (b)(4) items manufactured and released on 03-nov-2022.Expiration date: 2027-10-18.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

At about one year and one month from the primary, the patient came in reporting pain due to a loose cup and the cause of the loose cup is unknown.The surgeon revised the cup and liner and the surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø54 NO-HOLE
• Type of Device: ACETABULAR CUP
• 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: 18952031
• MDR Text Key: 338265992
• Report Number: 3005180920-2024-00122
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030810848
• UDI-Public: 07630030810848
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/21/2024

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: 01.32.154SH
• Device Lot Number: 2217482
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/03/2022
• 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: 36 YR
• Patient Sex: Female
• Patient Race: White