BONE SCR SELF-TAP NI 00625006530

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2020-03-30 for BONE SCR SELF-TAP NI 00625006530 manufactured by Zimmer Biomet, Inc..

Event Text Entries

[186676893] (b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device remains implanted. Once the investigation has been completed a follow-up mdr will be submitted. Concomitant medical products: part # 010000856/ liner / lot #6475495, part # 51-104110/ stem / lot #6479649, part #110017102/ shell / lot #6428483, part # 650-1057/biolox head/ lot #2958839, part # 650-1065/trp sleve / lot #2950541. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2020 -01320, 0001825034 -2020 -01321, 0001825034 -2020 -01322.
Patient Sequence No: 1, Text Type: N, H10


[186676894] It was reported 3 months post implantation patient is allegedly experiencing hives, burning, swelling and pain into the thigh. Right hip remains implanted. The patient is going to have a metal allergy test conducted; however, no results have been provided to date. Attempts have been made and additional information on the reported event is unavailable at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001825034-2020-01323
MDR Report Key9899957
Report SourceCONSUMER,HEALTH PROFESSIONAL
Date Received2020-03-30
Date of Report2020-03-30
Date Mfgr Received2020-03-05
Date Added to Maude2020-03-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DR.
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1ZIMMER BIOMET, INC.
Manufacturer Street56 E. BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal Code46582
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBONE SCR SELF-TAP
Generic NamePROSTHESIS, HIP
Product CodeLPH
Date Received2020-03-30
Model NumberNI
Catalog Number00625006530
Lot Number64356267
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER BIOMET, INC.
Manufacturer Address56 E. BELL DRIVE WARSAW IN 46582 US 46582


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-30

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