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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY MODULAR FEMORAL STEM PROSTHESIS, HIP

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ZIMMER, INC. ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY MODULAR FEMORAL STEM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion
Event Date 07/11/2014
Event Type  Injury  
Manufacturer Narrative

(b)(4). The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental mdr will be submitted. Concomitant medical products: versys hip system femoral head , p/n 00801803602; kinectiv technology modular neck g, p/n 00784802300; zimmer m/l taper hip prosthesis with kinectiv technology modular femoral stem, p/n 00771301000; trident cluster acetabular shell p/n 542-11-54f; trident x3 0 polyethylene insert p/n 623-00-36f. Multiple mdr reports were filed for this event. Please see associated reports: 0001822565-2017-03760, 0001822565-2017-03761 and 0001822565-2017-03762.

 
Event Description

It was reported that patient underwent a revision procedure five years post-implantation due to implant corrosion and adverse local tissue reaction with a pseudotumor and trunionnosis. Operative notes report the patient had corrosion between the neck and the head. A large amount of blackened tissue surrounding the taper junction on the trunnion was identified. Furthermore, corrosion products were identified within the taper junction of the femoral head itself. Attempts to obtain additional information have been made; however, no more is available.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Reported event was confirmed by review of operative notes. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Review of the complaint history determined that no further action is required as no were trends identified. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.

 
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Brand NameZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY MODULAR FEMORAL STEM
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key6604024
Report Number0001822565-2017-03762
Device Sequence Number1
Product CodeKWA
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/14/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/01/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number00771301000
OTHER Device ID NumberN/A
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 Received05/22/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 06/01/2017 Patient Sequence Number: 1
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