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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. BIOMET UNKNOWN TAPERLOC STEM HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Hematoma (1884); Necrosis (1971); Impaired Healing (2378)
Event Date 12/03/2014
Event Type  Injury  
Manufacturer Narrative
(b)(4). Device history record 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, head, 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 - 05126, 0001825034 - 2018 - 05127, 0001825034 - 2018 - 05129.
 
Event Description
It was reported that approximately 6 weeks post implantation, the patient had presented with wound-edge necrosis, which resulted in wound dehiscing. The patient subsequently underwent an irrigation and debridement of the surgical wound due to non-healing, secondary to wound necrosis, and a hematoma found during the procedure. Wound healing was also compromised by infection. Attempts have been made, and no further information has been provided.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Reported event was able to be confirmed through review of op notes. 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.
 
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Brand NameBIOMET UNKNOWN TAPERLOC STEM
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 Key7759028
MDR Text Key116356949
Report Number0001825034-2018-05125
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,Followup
Report Date 10/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2018
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 Received09/24/2018
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: 08/07/2018 Patient Sequence Number: 1
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