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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 52/28 DOUBLE MOBILITY LINER

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MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 52/28 DOUBLE MOBILITY LINER Back to Search Results
Model Number 01.26.2852MHC
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 12/03/2020
Event Type  Injury  
Manufacturer Narrative
Batch review performed on 14 december 2020 lot 1909378: (b)(4) items manufactured and released on 22-jan-2020. Expiration date: 2024-12-14. 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 item involved in the event: ball heads: mectacer 01. 29. 202 biolox delta ceramic ball head 12/14 ¿ 28 size m 0 (k112115) lot. 1909750 batch review performed on 14 december 2020 lot 1909750: (b)(4) items manufactured and released on 03-mar-2020. Expiration date: 2025-02-17. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been already sold without two similar reported events.
 
Event Description
The patient came in, 5 months after primary surgery, due to signs of an infection and the pathogen is unknown. The surgeon performed a washout and revised the head and liner. The surgery was completed successfully.
 
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Brand NameLINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 52/28
Type of DeviceDOUBLE MOBILITY 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 Key11075684
MDR Text Key223703844
Report Number3005180920-2020-00965
Device Sequence Number1
Product Code MEH
UDI-Device Identifier07630030807343
UDI-Public07630030807343
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 company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number01.26.2852MHC
Device Catalogue Number01.26.2852MHC
Device Lot Number1909378
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/22/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/28/2020 Patient Sequence Number: 1
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