• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER BIOMET, INC. BIOMET UNKNOWN SHELL HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Bacterial Infection (1735); Fever (1858)
Event Date 11/11/2011
Event Type  Injury  
Manufacturer Narrative
(b)(4). Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown. 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. Unique identifier (udi) #: n/a. Concomitant medical products: item # unk, stem, lot # unk; item # unk, head, lot # unk; item # unk, liner, lot # unk. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-04881, 0001825034-2018-04883, 0001825034-2018-04888.
 
Event Description
It was reported that approximately one month post implantation, a patient had presented with fever, severe redness, and drainage from the surgical wound. Radiographs revealed that the components were well-fixed and positioned. Patient thus underwent an incision and drainage with wound closure and application of wound v. A. C on the affected hip due to non-healing and wound infection. A hemovac drain was also placed. 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 can be confirmed by 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. 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBIOMET UNKNOWN SHELL
Type of DeviceHIP PROSTHESIS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7756405
MDR Text Key116216989
Report Number0001825034-2018-04885
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
PNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Type of Report Initial,Followup
Report Date 08/22/2018
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/07/2018 Patient Sequence Number: 1
-
-