MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 48; HIP ACETABULAR SHELL

Catalog Number	01.26.45.0048
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 april 2019, lot 161590: (b)(4) items manufactured and released on 14-jun-2016.Expiration date: 2021-06-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director.Acetabular component revision surgery in a (b)(6) year old woman.Radiographic image provided shows the presence of bone quality alterations and areas of reduced bone density in the proximal part of the acetabulum.The result of this situation was a cup loosening with consequent instability of the joint.Aseptic loosening is a possible literature described adverse event after cementless total hip arthroplasty and causes are often unknown.The cause of this event cannot be determined.
Event or Problem Description
Revision surgery performed due to cup mobilization, 2 years and 4 months after primary.The cup has been replaced with double mobility system, inlay and head have been replaced as well.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 48
• Common Device Name: HIP ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8508149
• Report Number: 3005180920-2019-00270
• Device Sequence Number: 11202909
• Product Code: LZO
• UDI-Device Identifier: 07630030807756
• UDI-Public: 07630030807756
• 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: 2016
• 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): 04/12/2019

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: 06/02/2021
• Device Catalogue Number: 01.26.45.0048
• Device Lot Number: 161590
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 04/12/2019
• 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: 66 YR
• Patient Weight: 95