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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC STEM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TAPERLOC STEM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Foreign Body Reaction (1868); Post Operative Wound Infection (2446)
Event Date 06/01/2016
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products. Concomitant medical products: unknown - unknown head¿ unknown, unknown - unknown shell¿ unknown, unknown - unknown liner¿ unknown. Therapy date: (b)(6) 2016. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the location of the device is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2018 -06069, 0001825034 -2018 -06070, 0001825034 -2018 -06072.
 
Event Description
It was reported patient presented with drainage from hip approximately 1 month post initial right total hip arthroplasty. Irrigation and debridement was performed. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Reported event confirmed due to medical records received from the customer. No device was returned for evaluation. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.
 
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Brand NameTAPERLOC STEM
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7752944
MDR Text Key116121170
Report Number0001825034-2018-06067
Device Sequence Number0
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Model 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 Received08/09/2018
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: 08/06/2018 Patient Sequence Number: 1
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