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

Catalog Number	01.32.148MB
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At 5 months and a half from the primary, the patient came in reporting pain due to impingement by the cup.The surgeon revised the 48mm cup with a 52mm cup and added more inclination.The surgeon also revised the head and liner and added a biolox option sleeve.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 04 december 2023 lot 2219702: 32 items manufactured and released on 14-feb-2023.Expiration date: 2028-jan-29.No anomalies found related to the problem.To date, 24 items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48
• Common Device Name: HIO 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: 18355544
• Report Number: 3005180920-2023-01026
• Device Sequence Number: 6924390
• Product Code: LPH
• UDI-Device Identifier: 07630030860959
• UDI-Public: 07630030860959
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143453
• 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): 12/19/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 01.32.148MB
• Device Lot Number: 2219702
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2023
• 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: 42 YR
• Patient Sex: Female
• Patient Race: White