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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H, HA COATED STEM SIZE 1 STD CEMENTLESS FEMORAL STEM

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MEDACTA INTERNATIONAL SA AMISTEM H, HA COATED STEM SIZE 1 STD CEMENTLESS FEMORAL STEM Back to Search Results
Catalog Number 01.18.131
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem Joint Disorder (2373)
Event Type  Injury  
Manufacturer Narrative

On 18 august 2017 the medical affairs director performed a clinical evaluation and commented as follows: partial revision (femoral stem) in cementless double mobility tha on a young lady after two years. The stem appears to be loose on the supplied radiographs. Some sclerotic lines are also visible around the cup, which has not been revised though. The stem appears to have a rather significant anteversion but this cannot be assumed to be the cause for loosening. Aseptic loosening is a possible adverse event following tha and very often, like in this case, the main cause remains unknown. Batch reviews performed on 21 august 2017. Lot 150841: (b)(4) items manufactured and released on 26 may 2015. Expiration date: 2020-04-30. No anomalies found related to the reported issue. To date, (b)(4) items of the same lot have been already sold without any similar reported event. Mectacer biolox delta ceramic ball head 12/14 ø 28 size l +3. 5, code 01. 29. 203, lot. 148656 (k112115). (b)(4) items manufactured and released on 17 march 2015. Expiration date: 2020-02-29. 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. Versafitcup double mobility hc liner ø 48/28, code 01. 26. 2848mhc, lot. 151096 (k092265) (b)(4) items manufactured and released on 07 july 2015. Expiration date: 2020-05-31. 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 Description

The patient came in complaining of laxity. The cause of laxity is unknown. The surgeon revised the stem, head, and liner. The surgery was completed successfully. X-rays are available. Explants will not become available.

 
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Brand NameAMISTEM H, HA COATED STEM SIZE 1 STD
Type of DeviceCEMENTLESS FEMORAL STEM
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, 6874
SZ   6874
MDR Report Key6812710
MDR Text Key83366427
Report Number3005180920-2017-00462
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK093944
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 08/23/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/23/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2020
Device Catalogue Number01.18.131
Device LOT Number150841
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/24/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/26/2015
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: 08/23/2017 Patient Sequence Number: 1
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