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

Catalog Number 01.26.2848MHC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Disorder (2373)

Event Date 06/10/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 21.06.2019: lot: 164724: (b)(4) items manufactured and released on 18.10.2016.Expiration date: 02.10.2021.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs director: 2 years after primary cementless dm tha the patient reports pain and instability.The intraoperative image supplied does not help in any way, the components seem to be correctly positioned.The surgeon replaced the components with identical ones (same sizes) so we cannot draw any useful hint from the replacements chosen.We are unable to draw any conclusion.Additional implant involved in the event, batch review performed on 21.06.2019: ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot.167029.Lot 167029: (b)(4) items manufactured and released on 30.01.2017.Expiration date: 18.01.2022.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Document review performed by ceramic head manufacturer (ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot.167029): due to lack of information of the laser engraving, the identification of the ball head is only possible based on the information provided by medacta.The ball head to the shop order (b)(4).Protocols and certificate of conformance were reviewed.The quality documents show that the values obtained on the ball head were according to the specification valid at the time of production.The component properties at the microstructure as obtained from the quality documents fulfill the requirements as specified at the time of production.There are no indications of any pre-existing material defects.Due to a lack of ceramic parts further investigations cannot be done.

Event Description

Revision surgery performed 2 years after the primary due to pain and instability (the cause is unknown).The surgeon revised the head and liner and the surgery was completed successfully.The surgeon revised the versafitcup dm liner hc 48/28 with versafitcup dm liner hc 48/28 and revised the 28mm biolox delta head m with a 28mm biolox option head.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMD
• Type of Device: DOUBLE MOBILITY HC LINER
• 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: 8770444
• MDR Text Key: 150374380
• Report Number: 3005180920-2019-00552
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807244
• UDI-Public: 07630030807244
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092265
• 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: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2021
• Device Catalogue Number: 01.26.2848MHC
• Device Lot Number: 164724
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2016
• 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