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

Catalog Number 01.32.148DH

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/13/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 332259782
• Report Number: 3005180920-2023-01056
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K132879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01.32.148DH
• Device Lot Number: 2310020
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/27/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian