MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 54; HIP ACETABULAR SHELL CEMENTLESS

Catalog Number	01.26.54MB
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 9 years 7 months after teh primary, the patient came in reporting pain due to a loose cup and the cause of the loose cup is unknown.The surgeon revised the medacta cup with a competitor cup and revised the medacta head and liner with a new medacta head and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 31 july 2023: lot 132692: (b)(4) items manufactured and released on 18-oct-2013.Expiration date: 2018-09-30.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 54
• Common Device Name: HIP ACETABULAR SHELL 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: 17489440
• Report Number: 3005180920-2023-00642
• Device Sequence Number: 7252730
• Product Code: MEH
• UDI-Device Identifier: 07630030808128
• UDI-Public: 07630030808128
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 08/09/2023

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 Expiration Date: 09/30/2018
• Device Catalogue Number: 01.26.54MB
• Device Lot Number: 132692
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2013
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Race: Black Or African American