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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET UNKNOWN HEAD HIP PROSTHESIS

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ZIMMER BIOMET, INC. BIOMET UNKNOWN HEAD HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Bacterial Infection (1735); Impaired Healing (2378)
Event Date 04/02/2007
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted. Reported event was unable to be confirmed due to limited information received from the customer. 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. 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. Concomitant medical products: item # unk, stem, lot # unk. Item # unk, shell, lot # unk. Item # unk, liner, lot # unk. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-04936, 0001825034-2018-04939, 0001825034-2018-04941.
 
Event Description
It was reported that approximately 2 weeks post implantation, patient had presented with bloody, yellow drainage from mild distal incision. Patient was thus admitted for observation and treated with iv antibiotics. Subsequently, patient underwent irrigation and debridement due to non-healing surgical wound. Attempts have been made, and no further information has been provided.
 
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Brand NameBIOMET UNKNOWN HEAD
Type of DeviceHIP PROSTHESIS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7746975
MDR Text Key115936119
Report Number0001825034-2018-04938
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Reporter Occupation
Type of Report Initial
Report Date 07/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received07/12/2018
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

Patient Treatment Data
Date Received: 08/03/2018 Patient Sequence Number: 1
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