MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP 01.26.46MB ACETABULAR SHELL Ø 46; HIP ACETABULAR SHELL

Model Number	01.26.46MB
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04-aug-2022 lot 181686: 15 items manufactured and released on 24-jul-2018.Expiration date: 2023-07-08.No anomalies found related to the problem.To date, 13 items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
At about 3 years and 6 months after the primary surgery, the patient came reporting pain due to a loose cup and the cause is unknown.The surgeon revised successfully the medacta cup and liner with competitor components and revised the medacta head with a medacta head.

• Brand Name: CUP: VERSAFITCUP 01.26.46MB ACETABULAR SHELL Ø 46
• Common Device Name: HIP ACETABULAR 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15335950
• Report Number: 3005180920-2022-00654
• Device Sequence Number: 6927391
• Product Code: MEH
• UDI-Device Identifier: 07630030808012
• UDI-Public: 07630030808012
• 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: 2019
• Device Explanted Year: 2022
• 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): 09/01/2022

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: 01.26.46MB
• Device Catalogue Number: 01.26.46MB
• Device Lot Number: 181686
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2022
• 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