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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-H PROXIMAL COATING STD STEM SIZE 8; CEMENTLESS HIP STEM
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MEDACTA INTERNATIONAL SA AMISTEM-H PROXIMAL COATING STD STEM SIZE 8; CEMENTLESS HIP STEM Back to Search Results
Catalog Number 01.18.178
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 07/06/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 july 2018: lot 171674: (b)(4) items manufactured and released on 30 august 2017.Expiration date: 2022-08-17.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
The patient came in complaining of pain 1 month after primary.The surgeon determined that the patient fractured near the distal end of the stem.The surgeon revised the stem and head with another company's product.The cup and liner remain in place.The surgery was completed successfully.
 
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Brand Name
AMISTEM-H PROXIMAL COATING STD STEM SIZE 8
Common Device Name
CEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7726662
Report Number3005180920-2018-00571
Device Sequence Number1269897
Product Code LZO
UDI-Device Identifier07630030804434
UDI-Public07630030804434
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K161635
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/27/2018
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 Date08/17/2022
Device Catalogue Number01.18.178
Device Lot Number171674
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/05/2018
Initial Report FDA Received Date07/27/2018
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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