MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø62 MULTI-HOLE; HIP ACETABULAR CUP

Catalog Number	01.32.162MH
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	12/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 january 2024.Lot 186876: (b)(4) manufactured and released on 17-jan-2019.Expiration date: 2024-01-02.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with another similar reported event during the period of review.
Event or Problem Description
The patient had a primary hip surgery with a competitor at an unknown date.Subsequently, the patient was revised for an unknown reason and a medacta cup, head and liner were implanted on (b)(6) 2023.Presently, on (b)(6) 2023 the patient came in reporting pain due to a loose cup.The surgeon revised the medacta cup and liner with a competitor's product and revised the medacta head with another medacta head.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø62 MULTI-HOLE
• Common Device Name: HIP 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: 18474064
• Report Number: 3005180920-2023-01083
• Device Sequence Number: 6398415
• Product Code: LPH
• UDI-Device Identifier: 07630030810985
• UDI-Public: 07630030810985
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/02/2024
• Device Catalogue Number: 01.32.162MH
• Device Lot Number: 186876
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Race: White