MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT 01.32.156MH ACETABULAR SHELL Ø56 MULTI-HOLE LOT. 1901400; HIP ACETABULAR SHELL Ø56 MULTI-HOLE

Model Number 01.32.156MH

Device Problems Failure to Osseointegrate (1863); Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 05/02/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 03 may 2023: lot 1901400: (b)(4) items manufactured and released on 28-jun-2019.Expiration date: 2024-06-17.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event in the period of review.

Event Description

Revision surgery for shell loosening, about 9 months post-primary.The surgeon revised the medacta cup and liner with competitor components and revised the medacta head with a medacta head.The surgery was completed successfully.

• Brand Name: CUP: MPACT 01.32.156MH ACETABULAR SHELL Ø56 MULTI-HOLE LOT. 1901400
• Type of Device: HIP ACETABULAR SHELL Ø56 MULTI-HOLE
• 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: 17036587
• MDR Text Key: 316287543
• Report Number: 3005180920-2023-00372
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030810862
• UDI-Public: 07630030810862
• 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: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 01.32.156MH
• Device Catalogue Number: 01.32.156MH
• Device Lot Number: 1901400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/28/2019
• 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