MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 56; HIP ACETABULAR SHELL

Catalog Number	01.26.45.0052
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 june 2019: lot 176627: (b)(4) items manufactured and released on 12 february 2018.Expiration date: 2023-02-01.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs department: acetabular component revision performed 1 year after cementless total hip arthroplasty in a (b)(6) woman.The patient was complaining about pain probably caused by suboptimal cup position.The reason of this position cannot be assessed not having peroperative images: patient anatomy or bone morphology may be a possible cause.No reason to suspect that this event is due to a faulty device.Visual inspection performed by r&d project manager: cup shows ha residuals on outer surface.Signs of extraction on the edge.Pe shows sign of removal.No particular signs on the femoral head.
Event or Problem Description
Revision surgery after 1 year and 1 month from the primary due to pain caused by mechanical conflict with the psoas.The cup has been revised.The cup was probably in bad position and oversized.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 56
• Common Device Name: HIP ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8739735
• Report Number: 3005180920-2019-00514
• Device Sequence Number: 2296531
• Product Code: LZO
• UDI-Device Identifier: 07630030807770
• UDI-Public: 07630030807770
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2019

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: 02/01/2023
• Device Catalogue Number: 01.26.45.0052
• Device Lot Number: 176627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 06/27/2019
• 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
• Patient Age: 69 YR
• Patient Weight: 75