• 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. TPRLC 133 MP TYPE1 PPS HO 13.0 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. TPRLC 133 MP TYPE1 PPS HO 13.0 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Material Erosion (1214); Activation, Positioning or SeparationProblem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Failure of Implant (1924); Necrosis (1971); Pain (1994); Ambulation Difficulties (2544); Metal Related Pathology (4530); Swelling/ Edema (4577)
Event Date 09/14/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device will not be returned for analysis location unknown; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 03031, 0001825034 - 2021 - 03032, 0001825034 - 2021 - 03034.
 
Event Description
It was reported that patient underwent tha on right hip procedure. Patient underwent procedure on four (4) years post implantation to remove a pseudotumor. Subsequently, patient underwent a revision procedure two (2) months later. It was relayed that elevated chromium and cobalt levels were confirmed. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTPRLC 133 MP TYPE1 PPS HO 13.0
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 Key12738767
MDR Text Key279609004
Report Number0001825034-2021-03033
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110400
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number51-107130
Device Lot Number2853247
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/30/2012
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: 11/02/2021 Patient Sequence Number: 1
-
-