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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 50 ACETABULAR CUP

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MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 50 ACETABULAR CUP Back to Search Results
Catalog Number 01.26.50MB
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Date 12/05/2019
Event Type  Injury  
Manufacturer Narrative
Batch review performed on 16 december 2019: lot 1902300: (b)(4) items manufactured and released on 27-ago-2019. Expiration date: 2024-08-17. 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 implant involved: liner: versafitcup dm 01. 26. 2850mhc double mobility hc liner 50/28 (k092265) lot. 1904369. Batch review performed on 16 december 2019: lot 1904369: (b)(4) items manufactured and released on 05-sept-2019. Expiration date: 2024-08-25. 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 implant involved: ball heads: mectacer 01. 29. 202 biolox delta ceramic ball head 12/14 28 size m 0 (k112115) lot. 1903847 batch review performed on 16 december 2019: lot 1903847: 210 items manufactured and released on 26-jul-2019. Expiration date: 2024-07-13. No anomalies found related to the problem. To date, 118 items of the same lot have been already sold without any similar reported event.
 
Event Description
The patient came in due to signs of an infection and the pathogen is unknown. About 2 weeks after primary the surgeon performed a washout and revised the head, liner, and cup and the surgery was completed successfully.
 
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Brand NameCUP: VERSAFITCUP ACETABULAR SHELL Ø 50
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 Key9510720
MDR Text Key188115788
Report Number3005180920-2019-01106
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 company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number01.26.50MB
Device Lot Number1902300
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/27/2019
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: 12/23/2019 Patient Sequence Number: 1
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