SULOX, HEAD, M? 32/0, TAPER 12/14 N/A 17.32.06

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-08-03 for SULOX, HEAD, M? 32/0, TAPER 12/14 N/A 17.32.06 manufactured by Zimmer Gmbh.

Event Text Entries

[115894752] (b)(4). Concomitant medical products and therapy dates: detail of product : associated item number: 00000004265, item name: alloft-s alloclassic shl 52/ii, lot #: 2452071. Associated item number: 290039090, item name: cls spotorno, stem, 135, uncemented, 9. 0, taper 12/14, lot #: 2437399. Associated item number: 0100013509, item name: durasul, alpha insert, hooded, ii/32, lot #: 2456420. The manufacturer received x-rays and other source documents for review. The manufacturer did not receive the device for investigation. The device history records were reviewed and found to be conforming. Additional information has been requested and is currently not available. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available, an updated report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[115894753] It was reported that about 9 years after the implantation the patient underwent revision surgery due the fracture of the implant.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0009613350-2018-00748
MDR Report Key7745977
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2018-08-03
Date of Report2018-11-29
Date of Event2018-06-21
Date Mfgr Received2018-11-15
Device Manufacturer Date2008-06-17
Date Added to Maude2018-08-03
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 GMBH
Manufacturer StreetSULZER ALLEE 8 SULZER INDUSTRIE PARK
Manufacturer CityWINTERTHUR 8404
Manufacturer CountrySZ
Manufacturer Postal Code8404
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameSULOX, HEAD, M? 32/0, TAPER 12/14
Generic NameN/A
Product CodeKWB
Date Received2018-08-03
Returned To Mfg2018-07-25
Model NumberN/A
Catalog Number17.32.06
Lot Number2460651
Device Expiration Date2013-05-31
OperatorLAY USER/PATIENT
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerZIMMER GMBH
Manufacturer AddressSULZER ALLEE 8 SULZER INDUSTRIE PARK WINTERTHUR 8404 SZ 8404


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2018-08-03

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