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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 48/28

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MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 48/28 Back to Search Results
Model Number 01.26.2848MHC
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Date 09/25/2020
Event Type  Injury  
Manufacturer Narrative
Batch review performed on 07 october 2020 lot 1909376: (b)(4) items manufactured and released on 29jann-2020. Expiration date: 2025-01-13. No anomalies found related to the problem. To date, 73 items of the same lot have been already sold with another similar reported event. Other device involved in the event: ball heads: mectacer 01. 29. 202 biolox delta ceramic ball head 12/14 ø 28 size m 0 lot. 1909750 (k112115). Batch review performed on 07 october 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, 185 items of the same lot have been already sold without any similar reported event.
 
Event Description
Revision surgery 21 days after primary for hip infection. The surgeon performed a washout and revised the head and liner. The surgery was completed successfully. The pathogen is unknown.
 
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Brand NameLINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 48/28
Type of DeviceDOUBLE 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 Key10697604
MDR Text Key211901470
Report Number3005180920-2020-00739
Device Sequence Number1
Product Code MEH
Combination Product (y/n)Y
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 10/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number01.26.2848MHC
Device Catalogue Number01.26.2848MHC
Device Lot Number1909376
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/29/2020
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: 10/19/2020 Patient Sequence Number: 1
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