MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL Ø 52

Catalog Number	01.26.52MB
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	05/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 june 2018.Lot 031327: (b)(4) items manufactured and released on (b)(4) 2004.Expiration date: 2009-03-01 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medical affairs director on 22 june 2018.Acetabular component revision occurred 14 years after primary implantation of a cementless total hip arthroplasty in a woman who was (b)(6) at time of surgery.Radiographic images provided show evident signs of osteolysis around the cup and in the proximal femur.It is conceivable that these signs could be originated by pe wear debris, particularly because the original implant was standard pe.The young patient is likely to have led an active life for 14 years and this may involve significant wear and wear-related osteolysis, but the cause cannot be determined with certainty.A lifetime of 14 years in a young patient is a normal result for a standard pe component, as described in literature.
Event or Problem Description
Revision due to aseptic loosening of the cup 10 years after primary surgery; the patient reported about limping and pain.

• Brand Name: VERSAFITCUP ACETABULAR SHELL Ø 52
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7633540
• Report Number: 3005180920-2018-00456
• Device Sequence Number: 11059517
• Product Code: MEH
• UDI-Device Identifier: 07630030808098
• UDI-Public: 07630030808098
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2018

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: 03/01/2009
• Device Catalogue Number: 01.26.52MB
• Device Lot Number: 031327
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2018
• Initial Report FDA Received Date: 06/25/2018
• 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