• 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 FP TYPE1 PPS SO 8.0 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 FP TYPE1 PPS SO 8.0 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Multiple mdr's were filed for this event. Please see associated report(s): 0001825034 - 2019 - 02469, 0001825034 - 2019 - 02470, 0001825034 - 2019 - 02471, 0001825034 - 2019 - 02472, 0001825034 - 2019 - 02473, 0001825034 - 2019 - 02474, 0001825034 - 2019 - 02475, 0001825034 - 2019 - 02476, 0001825034 - 2019 - 02477, 0001825034 - 2019 - 02479, 0001825034 - 2019 - 02480, 0001825034 - 2019 - 02481, 0001825034 - 2019 - 02482, 0001825034 - 2019 - 02483, 0001825034 - 2019 - 02484, 0001825034 - 2019 - 02485, 0001825034 - 2019 - 02486, 0001825034 - 2019 - 02487. Concomitant medical products: item # item name lot number primary di# 51-104160 tprlc 133 t1 pps ho 16x152mm 3817553 00880304491854,  51-104160 tprlc 133 t1 pps ho 16x152mm 6028661 00880304491854,  51-104140 tprlc 133 t1 pps ho 14x148mm 3817531 00880304491847,  51-103180 tprlc 133 t1 pps so 18x156mm 3975978 00880304498358,  51-103180 tprlc 133 t1 pps so 18x156mm 6022911 00880304498358,  51-103170 tprlc 133 t1 pps so 17x154mm 6238743 00880304498341,  51-103170 tprlc 133 t1 pps so 17x154mm 6133628 00880304498341,  51-103160 tprlc 133 t1 pps so 16x152mm 6309256 00880304489691,  51-103150 tprlc 133 t1 pps so 15x150mm 6118653 00880304491861 , 51-103140 tprlc 133 t1 pps so 14x148mm 6075801 00880304491816 , 51-103140 tprlc 133 t1 pps so 14x148mm 6170567 00880304491816,  51-103130 tprlc 133 t1 pps so 13x146mmtp 6308779 00880304489677,  51-103090 tprlc 133 type1 pps so 9x137mm 6462370 00880304498334 , 51-100080 tprlc 133 fp type1 pps so 8. 0 6364712 00-88030489660, 51-100060 tprlc 133 fp type1 pps so 6. 0 6289409 00880304498174 , 51-100060 tprlc 133 fp type1 pps so 6. 0 6273744 00880304498174,  51-100050 tprlc 133 fp type1 pps so 5. 0 6241443 00880304498167,  51-100040 tprlc 133 fp type1 pps so 4. 0 6246127 not released. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported the device packaging had damage that compromised sterility. No patient or surgical involvement as the issue was identified in the inventory warehouse. No further information is available at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTPRLC 133 FP TYPE1 PPS SO 8.0
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 Key8679093
MDR Text Key147340960
Report Number0001825034-2019-02483
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number51-100080
Device Lot Number6364712
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/29/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/08/2020
Was Device Evaluated by Manufacturer? Yes
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

-
-