BIOLOX PROSTHESIS HEAD 12/14 32MM S NK560

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-12 for BIOLOX PROSTHESIS HEAD 12/14 32MM S NK560 manufactured by Aesculap Ag.

Event Text Entries

[183275117] Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10


[183275118] It was reported that there was an issue with biolox prosthesis head. It was reported that the patient is (b)(6) years old. The patient had after 12 years a post-operative dislocation. The date of the initial surgery is unknown. The batch number of the sample is unknown. The acetabular cup and insert are not aesculap products. Pre- revision tests showed no sign of loosening of the stem, and the dislocation was most likely due to chronic wear of the insert over time. The revision surgery was scheduled for 26th february, where the insert and the femoral head will be replaced. A revision surgery was necessary. Additional information was not provided nor available / was not available. The adverse event/malfunction is filed under (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2020-00056
MDR Report Key9824495
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-12
Date of Report2020-03-12
Date of Event2020-02-17
Date Mfgr Received2020-02-18
Date Added to Maude2020-03-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS KERSTIN ROTHWEILER
Manufacturer StreetPO BOX 40
Manufacturer CityTUTTLINGEN, 78501
Manufacturer CountryGM
Manufacturer Postal78501
Manufacturer G1AESCULAP AG
Manufacturer StreetPO BOX 40
Manufacturer CityTUTTLINGEN, 78501
Manufacturer CountryGM
Manufacturer Postal Code78501
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIOLOX PROSTHESIS HEAD 12/14 32MM S
Generic NameHIP ENDOPROSTHETICS
Product CodeLWJ
Date Received2020-03-12
Model NumberNK560
Catalog NumberNK560
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP AG
Manufacturer AddressPO BOX 40 TUTTLINGEN, 78501 GM 78501


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-12

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