MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø52 MULTI-HOLE; HIP ACETABULAR SHELL MULTI-HOLE CEMENTLESS

Model Number	01.32.152MH
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery at 25 days from primary surgery due to cup loosening.Acetabular components were revised successfully.
Additional Manufacturer Narrative
Batch review performed on 29 march 2023: lot 2011719: (b)(4) items manufactured and released on 18-feb-2021.Expiration date: 2026-02-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø52 MULTI-HOLE
• Common Device Name: HIP ACETABULAR SHELL MULTI-HOLE CEMENTLESS
• 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: 16813625
• Report Number: 3005180920-2023-00279
• Device Sequence Number: 14875845
• Product Code: LPH
• UDI-Device Identifier: 07630030810800
• UDI-Public: 07630030810800
• 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): 04/26/2023

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 Expiration Date: 02/07/2026
• Device Model Number: 01.32.152MH
• Device Catalogue Number: 01.32.152MH
• Device Lot Number: 2011719
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2021
• 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 Sex: Female