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

Catalog Number	01.26.54MB
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/15/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8699969
• Report Number: 3005180920-2019-00462
• Device Sequence Number: 2103214
• Product Code: MEH
• UDI-Device Identifier: 07630030808128
• UDI-Public: 07630030808128
• 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: 2010
• 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): 06/14/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2014
• Device Catalogue Number: 01.26.54MB
• Device Lot Number: 092647
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 06/14/2019
• 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: 71 YR