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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD Ø28X47 HIP ACETABULAR BIPOLAR HEAD

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MEDACTA INTERNATIONAL SA BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD Ø28X47 HIP ACETABULAR BIPOLAR HEAD Back to Search Results
Model Number 25060.2847
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Insufficient Information (4580)
Event Date 03/24/2022
Event Type  Injury  
Manufacturer Narrative
Clinical evaluation performed by medical affairs department intraprosthetic dislocation 1 month after the partial hip prosthesis surgery in a 85 year old patient. Dislocation of the head from the bipolar cup is normally prevented by the retention mechanism. Technical analysis of the implant might reveal if a defect was present in said mechanism; to date we have no evidence of such situation. Conditions that may cause intra prosthetic dislocation in a well functioning bipolar cup are difficult to reproduce. With information at hand we are unable to draw any definitive conclusion. Batch review performed on (b)(6) 2022: lot 2103619: 12 items manufactured and released on (b)(6) 2021. Expiration date: (b)(6) 2026. No anomalies found related to the problem. To date, 4 items of the same lot have been sold without any similar reported event. Other device involved: ball heads: cocr 01. 25. 013 cocr ball head 12/14 ø 28 size l +3. 5, (k072857), lot. 2107132: 100 items manufactured and released on (b)(6) 2021. Expiration date: (b)(6) 2026. No anomalies found related to the problem. To date, 25 items of the same lot have been sold without any similar reported event.
 
Event Description
Luxation of the bipolar head from the metallic head (intra-prosthetic dislocation). The surgeon revised all components.
 
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Brand NameBALL HEADS: BIPOLAR HEAD BIPOLAR HEAD Ø28X47
Type of DeviceHIP ACETABULAR BIPOLAR HEAD
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 Key14157400
MDR Text Key289605019
Report Number3005180920-2022-00272
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K091967
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 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number25060.2847
Device Catalogue Number25060.2847
Device Lot Number2103619
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/08/2021
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: 04/20/2022 Patient Sequence Number: 1
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