• 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. TAPERLOC MICRO LAT FMRL 13.5MM PROSTHESIS, HIP

  • 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. TAPERLOC MICRO LAT FMRL 13.5MM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Corroded (1131); Material Erosion (1214)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
Event Date 12/04/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). No product was returned or pictures provided; visual and dimensional evaluations could not be performed. Medical records/radiographs were provided and reviewed by a health care professional. Review of the available records identified the following: painful mom with concern for elevated metal ions and localized soft tissue issues, changes with consistent with a brown bone metal articular debris, trunnion was in good shape but did have some trunnionosis, head and liner placed without complication. Review of the device history record(s) identified no deviations or anomalies during manufacturing. A definitive root cause cannot 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00663, 0001825034-2021-00664, 0001825034-2021-00665.
 
Event Description
It was reported that the patient underwent left hip arthroplasty. Subsequently, was revised approximately 11 years later due to metallosis, tissue damage, bone loss, pain, and loss of mobility. During the revision, trunnionosis was wound on the trunnion of the stem. No further event information available at the time of this report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTAPERLOC MICRO LAT FMRL 13.5MM
Type of DevicePROSTHESIS, HIP
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 Key12042987
MDR Text Key257504511
Report Number0001825034-2021-01867
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062994
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 06/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Model NumberN/A
Device Catalogue Number15-103207
Device Lot Number749980
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2008
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: 06/22/2021 Patient Sequence Number: 1
-
-