MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø48 TWO-HOLES; HIP ACETABULAR SHELL

Catalog Number 01.32.148DH

Device Problem Failure to Osseointegrate (1863)

Patient Problem Pain (1994)

Event Date 06/28/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 06-jul-2023.Lot 2200491: (b)(4) items manufactured and released on 29-mar-2022.Expiration date: 2027-03-15.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

About 1 year from the primary, the patient came in reporting pain due to a loose cup and the cause is unknown.The surgeon revised the medacta cup, liner and head.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø48 TWO-HOLES
• 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: 17389615
• MDR Text Key: 319752980
• Report Number: 3005180920-2023-00559
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030810732
• UDI-Public: 07630030810732
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01.32.148DH
• Device Lot Number: 2200491
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2022
• 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 Sex: Female