MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMF; HIP SHELL LINER

Catalog Number 01.26.2852MHC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Disorder (2373)

Event Date 09/18/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 30 september 2019: lot 120087: 60 items manufactured and released on 28-march-2012.Expiration date: 2017-02-28.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.Additional devices involved: batch reviews performed on 30 september 2019: cup: versafitcup 01.26.52 mb acetabular shell cc ø 52 (k083116) lot 121034: (b)(4) items manufactured and released on 26-jun -2012.Expiration date: 2017-05-31.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.Ball heads: mectacer 01.29.201 biolox delta ceramic ball head 12/14 ø 28 size s -3.5 (k112115) lot 115762: (b)(4) items manufactured and released on 3-apr-2012.Expiration date: 2017-02-28.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.

Event Description

The patient came in, three months after primary surgery, complaining of pain.The cause of the pain was an allergic reaction to nickel.Ths surgeon revised successfully head, cup and liner and implanted 36 mm biolox delta head s, mpact multi hole cup 56 mm and impact flat liner hc 36/f.

• Brand Name: LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMF
• Type of Device: HIP SHELL 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: 9191333
• MDR Text Key: 162692709
• Report Number: 3005180920-2019-00872
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807343
• UDI-Public: 07630030807343
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 01.26.2852MHC
• Device Lot Number: 120087
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/28/2012
• 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