MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø48 TWO-HOLES; HIP ACETABULAR CUP

Catalog Number	01.32.148DH
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was not possible to couple the poly liner to the cup.Attempting to insert the liner the cup dissociated from the acetabulum and a slight fracture was generated.Surgery finished with a cup of increased size and acetabular screws.No fracture fixation was needed.
Additional Manufacturer Narrative
Batch review performed on 20 december 2023: lot 2310020: 32 items manufactured and released on 27-sept-2023.Expiration date: 2028-09-12.No anomalies found related to the problem.To date, 17 items of the same lot have been sold without any similar reported (failure of coupling and bone fracture) event in the period of review.Additional implant involved, batch review performed on 20 december 2023: liner: impact 01.32.3239hct flat pe hc liner ø32/c (k103721) lot 2312013: 100 items manufactured and released on 17-july-2023.Expiration date: 2028-07-01.No anomalies found related to the problem.To date, 44 items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø48 TWO-HOLES
• 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: 18452644
• Report Number: 3005180920-2023-01056
• Device Sequence Number: 12535711
• Product Code: LPH
• UDI-Device Identifier: 07630030810732
• UDI-Public: 07630030810732
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/05/2024

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 Catalogue Number: 01.32.148DH
• Device Lot Number: 2310020
• 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: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2023
• 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 Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian