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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH SULOX HEAD, L, 28/+3.5, TAPER 12/14

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ZIMMER GMBH SULOX HEAD, L, 28/+3.5, TAPER 12/14 Back to Search Results
Model Number N/A
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 01/14/2018
Event Type  Injury  
Manufacturer Narrative

The manufacturer did not receive x-rays, or 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).

 
Event Description

Ceramic head broke in a left hip without trauma. The implantation and explantation dates are left empty as the device involved in this complaint is broken. Hence, no expiration date is captured, for the same reason.

 
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Brand NameSULOX HEAD, L, 28/+3.5, TAPER 12/14
Type of DeviceSULOX HEAD
Manufacturer (Section D)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7364850
MDR Text Key103267912
Report Number0009613350-2018-00368
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberPN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,OTHER
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/20/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/23/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberN/A
Device Catalogue Number17.28.07
Device LOT Number2818638
OTHER Device ID Number00889024416963
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/03/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 03/23/2018 Patient Sequence Number: 1
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