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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM DOUBLE MOBILITY HC LINER 50/28 HIP SHELL LINER

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MEDACTA INTERNATIONAL SA VERSAFITCUP DM DOUBLE MOBILITY HC LINER 50/28 HIP SHELL LINER Back to Search Results
Model Number 01.26.2850MHC
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Bacterial Infection (1735)
Event Date 04/19/2021
Event Type  Injury  
Manufacturer Narrative
Batch review performed on 30 april 2021: lot 2006366: (b)(4) items manufactured and released on 3-aug-2020. Expiration date: 2025-07-21. 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 april 2021: cup: mpact 01. 32. 150mb double mobility acetabular shell ¿50 (k143453) lot 2006087: (b)(4) items manufactured and released on 21-oct-2020. Expiration date: 2025-10-12. 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. Stem: quadra-p 01. 12. 121 quadra-p std stem size 1 (k181254) lot 2002666: (b)(4) items manufactured and released on 30-jun-2020. Expiration date: 2025-07-20. 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. 202 biolox delta ceramic ball head 12/14 ¿ 28 size m 0 (k112115) lot 2006678: (b)(4) items manufactured and released on 5-oct-2020. Expiration date: 2025-09-24. 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
1 month after the primary surgery the patient came in due to signs of an infection and the pathogen is staphylococcus aureus. The surgeon performed a washout and revised all implants. The surgery was completed successfully.
 
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Brand NameVERSAFITCUP DM DOUBLE MOBILITY HC LINER 50/28
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 Key11831972
MDR Text Key250866236
Report Number3005180920-2021-00387
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 05/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number01.26.2850MHC
Device Catalogue Number01.26.2850MHC
Device Lot Number2006366
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/03/2020
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: 05/17/2021 Patient Sequence Number: 1
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