MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL Ø52 NO-HOLE; HIP CEMENTLESS SHELL

Model Number	01.32.152SH
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	04/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 2 april 2023: lot 2243239: (b)(4) items manufactured and released on 14-feb-2023.Expiration date: 2028-01-26.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.Clinical evaluation performed by medacta medical affairs manager: revision surgery 2 months after primary tha due to shell mobilization in a 64 year old female patient.The surgery was completed successfully.From the radiographic images, the acetabular cup appears to have mobilized.In these conditions, it is very likely that part of the femoral stem may impinge with the acetabular rim and damage may occur.The cup has not found pressfit and primary stability and the reason of this event is unknown.
Event or Problem Description
Revision surgery at about 2 months post primary following shell mobilization.The surgery was completed successfully.

• Brand Name: MPACT ACETABULAR SHELL Ø52 NO-HOLE
• Common Device Name: HIP CEMENTLESS 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: 16893409
• Report Number: 3005180920-2023-00347
• Device Sequence Number: 17682872
• Product Code: LPH
• UDI-Device Identifier: 07630030810817
• UDI-Public: 07630030810817
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2023

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 Model Number: 01.32.152SH
• Device Catalogue Number: 01.32.152SH
• Device Lot Number: 2243239
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 05/09/2023
• 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: 64 YR
• Patient Sex: Female