MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 50; CEMENTLESS ACETABULAR CUP

Model Number	01.26.45.0050
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 march 2021: lot 125368: (b)(4) items manufactured and released on 28-jan-2013.Expiration date: 2017-12-31.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported event since 2017.Clinical evaluation performed by medical affairs director.Acetabular component revision performed 8 years after cementless total hip arthroplasty in a (b)(6) year old woman due to cup mobilization.Cup position after implantation cannot be assessed on the basis of images received.According to the report, the patient is overweight ((b)(6) kg) and suffered from avascular necrosis (avn) and dysplasia: these conditions have probably contributed to the cup loosening.We cannot determine the causes of this failure, but we see no reason to think that the prosthetic implant was defective.
Event or Problem Description
The patient returned to the surgeon due to pain.Investigations showed that the cup had migrated.The revision surgeon explained that he believed this was due to the patient original diagnosis of avascular necrosis (avn) and dysplasia.The bone was soft in the acetabulum and the patient has a high weight.7 years and 11 months after primary the surgeon revised successfully the acetabular components and the ceramic head.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 50
• Common Device Name: CEMENTLESS ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11654412
• Report Number: 3005180920-2021-00288
• Device Sequence Number: 3606442
• Product Code: LZO
• UDI-Device Identifier: 07630030807763
• UDI-Public: 07630030807763
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/13/2021

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: 12/31/2017
• Device Model Number: 01.26.45.0050
• Device Catalogue Number: 01.26.45.0050
• Device Lot Number: 125368
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/13/2021
• 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
• Patient Age: 64 YR
• Patient Weight: 120