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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 FP TYPE1 PPS SO 6.0 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TPRLC 133 FP TYPE1 PPS SO 6.0 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, 0001825034-2019-02485, 0001825034-2019-02486, 0001825034-2019-02487. Associated device(s), primary di# item #: 51-104160, item name: tprlc 133 t1 pps ho 16x152mm, lot number: 3817553, primary di#: (b)(4); 51-104160, tprlc 133 t1 pps ho 16x152mm, 6028661, (b)(4); 51-104140, tprlc 133 t1 pps ho 14x148mm, 3817531, (b)(4); 51-103180, tprlc 133 t1 pps so 18x156mm, 3975978, (b)(4); 51-103180, tprlc 133 t1 pps so 18x156mm, 6022911, (b)(4); 51-103170, tprlc 133 t1 pps so 17x154mm, 6238743, (b)(4); 51-103170, tprlc 133 t1 pps so 17x154mm, 6133628, (b)(4); 51-103160, tprlc 133 t1 pps so 16x152mm, 6309256, (b)(4); 51-103150, tprlc 133 t1 pps so 15x150mm, 6118653, (b)(4); 51-103140, tprlc 133 t1 pps so 14x148mm, 6075801, (b)(4); 51-103140, tprlc 133 t1 pps so 14x148mm, 6170567, (b)(4); 51-103130, tprlc 133 t1 pps so 13x146mmtp, 6308779, (b)(4); 51-103090, tprlc 133 type1 pps so 9x137mm, 6462370, (b)(4); 51-100080, tprlc 133 fp type1 pps so 8. 0, 6364712, (b)(4); 51-100060, tprlc 133 fp type1 pps so 6. 0, 6289409, (b)(4); 51-100060, tprlc 133 fp type1 pps so 6. 0, 6273744, (b)(4); 51-100050, tprlc 133 fp type1 pps so 5. 0, 6241443, (b)(4); 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.
 
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Brand NameTPRLC 133 FP TYPE1 PPS SO 6.0
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 Key8682299
MDR Text Key195632014
Report Number0001825034-2019-02484
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103755
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 Received06/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number51-100060
Device Lot Number6289409
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

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