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U.S. Department of Health and Human Services

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

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MEDACTA INTERNATIONAL SA LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMF HIP SHELL LINER Back to Search Results
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.
 
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Brand NameLINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMF
Type of DeviceHIP 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 Key9191333
MDR Text Key162692709
Report Number3005180920-2019-00872
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092265
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received10/15/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date02/28/2017
Device Catalogue Number01.26.2852MHC
Device Lot Number120087
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/28/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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