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

Catalog Number	01.26.2848M
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	08/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 august 2019: lot: 090897: (b)(4) items manufactured and released on 13-may-2009.Expiration date: 2014-04-30.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 medacta medical affairs director: double mobility liner and head exchange performed 10 years after implantation.According to the report, these components where changed due to leg length difference.This may be the consequence of standard polyethylene wear that is commonly seen and described in literature but also of changes in contralateral hip status that cannot be assessed on the radiographic image provided.The reason of this event cannot be determined.
Event or Problem Description
The patient came in, 9 years and 10 months after primary surgery, complaining of instability due to a leg length discrepancy.The surgeon revised the medacta liner and the competitor's head.Medacta cup and competitor's stem are still implanted.The surgery was completed successfully.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER 48/28
• Common Device Name: SHELL DOUBLE MOBILITY INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8987625
• Report Number: 3005180920-2019-00759
• Device Sequence Number: 2867261
• 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): 09/11/2019

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: 04/30/2014
• Device Catalogue Number: 01.26.2848M
• Device Lot Number: 090897
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 09/11/2019
• 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