MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 60/28

Catalog Number	01.26.2860MHC
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 january 2019.Lot 152106: (b)(4) items manufactured and released on 17 june 2015.Expiration date: 2020-04-30.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 medical affairs director on january 17, 2019.3 years after primary cementless dm thr an intraprosthetic dislocation occurred.The ceramic head, reportedly manufactured by a different company, dislocated from the pe liner.There are no indications as to possible causes for this event, such as traumas or extreme movements.We could not measure either the head of the pe insert and verify if a tolerance mismatch occurred, but it is unlikely given the significant time after primary implantation.No definite reason for this event could be ascertained with the information at hand.Preliminary investigation performed by r&d product manager on january 14, 2019 by r&d product manager: preliminary visual investigation on explanted component shows signs of friction between femoral head and metal cup, resulting in metal transfer on femoral head and wear of the acetabular component's edge and articulating surface.Scratches signs on the pe liner edge due to extraction and non-coherent function after dislocation.
Event or Problem Description
The patient came in, 3 years and 1 month after primary surgery, due to intra-prosthetic dislocation of the head from the liner.The surgeon revised the medacta cup, medacta liner and another company's head.The surgery was completed successfully.

• Brand Name: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 60/28
• Common Device Name: DOUBLE MOBILITY HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8260594
• Report Number: 3005180920-2018-01109
• Device Sequence Number: 19346953
• Product Code: MEH
• UDI-Device Identifier: 07630030807473
• UDI-Public: 07630030807473
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/18/2019

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: 04/30/2020
• Device Catalogue Number: 01.26.2860MHC
• Device Lot Number: 152106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 01/18/2019
• 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