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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL 62 ACETABULAR CUP

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MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL 62 ACETABULAR CUP Back to Search Results
Model Number 01.26.62MB
Device Problem Malposition of Device (2616)
Patient Problem Pain (1994)
Event Date 01/26/2021
Event Type  Injury  
Manufacturer Narrative
Batch review performed on 02 february 2021: lot 081319: (b)(4) items manufactured and released on 14-oct-2008. Expiration date: 2013-08-31. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been already sold. No other similar events have been reported since 2017. Clinical evaluation performed by medical affairs director: revision surgery performed 11 years after primary double-mobility total hip arthroplasty. No information concerning patient general health status is available. Radiographic images provided show suboptimal cup position: this may be the result of inadequate implant position during surgery or subsequent mobilization but this cannot be assessed not having immediate postoperative images; however, secondary cup migration is highly probable. The reason of this event cannot be determined, but there is no reason to suspect a faulty device.
 
Event Description
The patient came in reporting pain due to malpositioning of the cup. The cause of the malpositioned cup is unknown. The surgeon revised all the components with competitor hardware 10 years 11 months after the primary. The surgery was completed successfully.
 
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Brand NameCUP: VERSAFITCUP ACETABULAR SHELL 62
Type of DeviceACETABULAR CUP
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 Key11371451
MDR Text Key233251687
Report Number3005180920-2021-00139
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083116
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 02/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2013
Device Model Number01.26.62MB
Device Catalogue Number01.26.62MB
Device Lot Number081319
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/14/2008
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: 02/24/2021 Patient Sequence Number: 1
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