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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM COLLARED STEM HA COATED STEM SIZE 0 STD; CEMENTLESS FEMORAL STEM
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MEDACTA INTERNATIONAL SA AMISTEM COLLARED STEM HA COATED STEM SIZE 0 STD; CEMENTLESS FEMORAL STEM Back to Search Results
Catalog Number 01.18.230
Health Effect - Clinical Codes Pain (1994); Joint Disorder (2373)
Date of Event 09/26/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 october 2017.Lot 142368: (b)(4) items manufactured and released on 17 july 2014.Expiration date: 2019-06-30.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 or Problem Description
The patient came in complaining of pain.The surgeon determined that the stem potted.The surgeon revised the stem, head and liner.The surgery was completed successfully.
 
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Brand Name
AMISTEM COLLARED STEM HA COATED STEM SIZE 0 STD
Common Device Name
CEMENTLESS FEMORAL STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key6979314
Report Number3005180920-2017-00614
Device Sequence Number1345230
Product Code LZO
UDI-Device Identifier07630030804557
UDI-Public07630030804557
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K121011
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/26/2017
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 Date06/30/2019
Device Catalogue Number01.18.230
Device Lot Number142368
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/26/2017
Initial Report FDA Received Date10/26/2017
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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