MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO FLAT PE LINER 32 / E; HIP SHELL LINER

Model Number	01.26.3244STT
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	12/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 december 2020: lot 143438: (b)(4) items manufactured and released on 08-sep-2014.Expiration date: 2019-07-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event since 2016.The device analysis will be performed on the third week of january when the r&d project manager will be in the office and the analysis can be done on the device.
Event or Problem Description
Worn inlay of a versafitcup cc trio implanted on 2014, osteolysis in the femur.Revision performed on (b)(6) 2020 (6 years and 2 months after primary), liner and head were replaced.
Additional Manufacturer Narrative
Visual inspection performed by medacta r&d project manager: from the received piece, particular scretches and damages were noticed on a portion of the rim of the liner; likely due to a repeated contact with the neck stem; in particular, the thickness of a region of the rim was minor respect to the opposite side probably due to the patient body load.There is no suspect of the presence of a third body as the surface of the ball head appeared to be not particular worn.

• Brand Name: VERSAFITCUP CC TRIO FLAT PE LINER 32 / E
• Common Device Name: HIP SHELL LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11169837
• Report Number: 3005180920-2021-00046
• Device Sequence Number: 11694037
• Product Code: LZO
• UDI-Device Identifier: 07630030807589
• UDI-Public: 07630030807589
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

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: 07/31/2019
• Device Model Number: 01.26.3244STT
• Device Catalogue Number: 01.26.3244STT
• Device Lot Number: 143438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention