FDA.reportPublic FDA data

MAUDE MDR 7984644

MDR report key
7984644
Report number
3005180920-2018-00801
Event key
0
Event type
3
Date of event
2018-09-19
Date received
2018-10-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR STEFANO BAJ
Address
STRADA REGINA CASTEL SAN PIETRO, SWITZERLAND 6874 SZ
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AMIS MOBILE LEG POSITIONER 2.0 FRAMESURGICAL INSTRUMENT FOR HIP SURGERIESMEDACTA INTERNATIONAL SALHX01.15.10.01901656236N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-10-1901. O

Event Narratives#

N

Patient 1

BATCH REVIEW PERFORMED ON 18 OCTOBER 2018. LOT 1656236: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 8 MARCH 2018. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, NO SIMILAR EVENT ON THE SAME LOT HAS BEEN REGISTERED. ADDITIONAL ITEM INVOLVED IN THE EVENT: STEM: AMIS-K 01.20.003 AMIS-K SIZE 2S1 STANDARD (NOT REGISTERED IN US), LOT 181278: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 APRIL 2017. EXPIRATION DATE:2023-04-12. 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. AMIS 01.15.10.0315 AMIS SHOE LOT 1754696: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 FEBRUARY 2018. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, NO SIMILAR EVENT ON THE SAME LOT HAS BEEN REGISTERED. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: FRACTURE OF A FEMORAL CONDYLE WAS DETECTED AFTER PRIMARY THA WITH CEMENTED FEMORAL STEM. THE RELATIONSHIP BETWEEN THE FRACTURE AND THE HIP OPERATION IS UNKNOWN AND QUITE UNLIKELY. WE SEE NO POSSIBILITY THAT THIS MAY HAVE BEEN CAUSED BY A FAULTY DEVICE.

D

Patient 1

FEMORAL CONDYLE BONE FRACTURE DISCOVERED THROUGH THE X-RAYS AFTER HIP SURGERY. IT IS UNKNOWN WHEN THE FRACTURE OCCURRED BECAUSE NO X-RAYS AROUND THE KNEE WERE TAKEN BEFORE THE SURGERY. THE PATIENT WILL BE FOLLOWED-UP.