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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P LAT STEM SIZE 4; CEMENTLESS HIP STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM P LAT STEM SIZE 4; CEMENTLESS HIP STEM Back to Search Results
Catalog Number 01.18.414
Date of Event 07/03/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 july 2019: lot 179949: (b)(4) items manufactured and released on 03-may-2018.Expiration date: 2023-04-23.No anomalies found related to the problems.To date, (b)(4) items of the same lot have been already sold without any similar reported events (per operative bone fractures and implant mobilization).Clinical evaluation performed by medical affairs director: femoral component revision performed 8 months after primary cementless total hip arthroplasty.During primary procedure, cerclage wiring was used due to a trochanteric fracture.The initial stem position cannot be assessed on the basis of the pre-revision images, however it is possible that the stem subsided due to the presence of the trochanteric fracture.The reason of this event cannot be determined.
 
Event or Problem Description
7 months after primary the patient had a revision surgery due to stem mobilization.The stem and head have been replaced successfully.During the primary surgery performed in (b)(6) 2018 the surgeon had a per-operative great trochanter fracture, treated with cerclage.Nobody of medacta was aware of the fracture till this complaint notification.
 
Additional Manufacturer Narrative
On february 26th 2020 we have received the item involved in the event.Visual inspection performed by medacta r&d hip project manager: from the received pieces it was not possible to note any particular sign related to the event; for these reasons, it is not possible to determine with certainty the root cause of the event, but we can exclude a failure of the device.
 
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Brand Name
STEM: AMISTEM P LAT STEM SIZE 4
Common Device Name
CEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key8835297
Report Number3005180920-2019-00634
Device Sequence Number14138762
Product Code LZO
UDI-Device Identifier07630040720137
UDI-Public07630040720137
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K173794
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 03/26/2020
1 Device 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 Date04/23/2023
Device Catalogue Number01.18.414
Device Lot Number179949
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/03/2019
Supplement Date Received by Manufacturer07/03/2019
Initial Report FDA Received Date07/29/2019
Supplement Report FDA Received Date03/26/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
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