MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL CC Ø 54

Catalog Number 01.26.54MB

Device Problem Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 05/15/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 14 june 2019: lot 092647: (b)(4) items manufactured and released on 25-jan-2010.Expiration date: 2014-12-31.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: 9 years after primary cementless tha with double mobility cup the patient complains of pain.The images provided show a malpositioned and oversized cup, but we cannot determine if this position is the result of migration or it's the original implant position because the we cannot read dates on radiographs.It is conceivable, based on the scarce information supplied, that the origin of pain is the laterally protruding cup.The exchange of head and liner is routine in this case.According to report, none of the implanted devices has malfunctioned.

Event Description

Revision surgery performed 8 years and 7 months after primary due to hip pain and tightness.During the revision surgery the stem and the cup were well fixed, the liner and the ball head have been revised as standard procedure.The images provided show a malpositioned and oversized cup, and it is conceivable, based on the scarce information supplied, that the origin of pain is the laterally protruding cup.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL CC Ø 54
• Type of Device: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8699969
• MDR Text Key: 148050151
• Report Number: 3005180920-2019-00462
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030808128
• UDI-Public: 07630030808128
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K083116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/14/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Catalogue Number: 01.26.54MB
• Device Lot Number: 092647
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 06/14/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR