MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 48/28; HIP DOUBLE MOBILITY LINER

Catalog Number	01.26.2848M
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	03/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 april 2019: lot 083746: (b)(4) items manufactured and released on 04-mar-2009.Expiration date: 2013-12-31.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 medica affairs director: hip revision surgery occurred more than 9 years after double-mobility total hip arthroplasty.A standard polyethylene dual mobility liner had been originally implanted and coupled with a competitor stem.Some wear of a double mobility liner after 9 years is normal; the osteolytic response depends on individual factors.According to the information received, the stem neck was not polished.Medacta double-mobility cups were not tested when coupled with competitor stems: their behaviour cannot be predicted in this condition.
Event or Problem Description
Revision surgery 9.5 years and a half after primary for osteolysis.The surgeon revised cup and liner successfully.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 48/28
• Common Device Name: HIP DOUBLE MOBILITY LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8473652
• Report Number: 3005180920-2019-00228
• Device Sequence Number: 19211343
• Product Code: MEH
• UDI-Device Identifier: 07630030807237
• UDI-Public: 07630030807237
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2019

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: 12/31/2013
• Device Catalogue Number: 01.26.2848M
• Device Lot Number: 083746
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 04/02/2019
• 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