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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BIPOLAR HEAD 28X45; HIP BIPOLAR HEAD
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MEDACTA INTERNATIONAL SA BIPOLAR HEAD 28X45; HIP BIPOLAR HEAD Back to Search Results
Model Number 25060.2845
Health Effect - Clinical Code Joint Dislocation (2374)
Date of Event 07/29/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2020: lot 186809: 20 items manufactured and released on 10-dec-2018.Expiration date: 2023-11-28.No anomalies found related to the problem.To date, 19 items of the same lot have been already sold without any other similar reported event.
 
Event or Problem Description
The patient came in reporting pain due to a dislocation of the femoral bipolar head from the acetabulum (bone).The surgeon revised the bipolar head 3 months after primary.The surgery was completed successfully.
 
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Brand Name
BIPOLAR HEAD 28X45
Common Device Name
HIP BIPOLAR HEAD
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10458658
Report Number3005180920-2020-00552
Device Sequence Number16694119
Product Code KWY
UDI-Device Identifier07630030843617
UDI-Public07630030843617
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K091967
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date11/28/2023
Device Model Number25060.2845
Device Catalogue Number25060.2845
Device Lot Number186809
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/29/2020
Initial Report FDA Received Date08/27/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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