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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 18X156MM; PROSTHESIS,HIP
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ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 18X156MM; PROSTHESIS,HIP Back to Search Results
Catalog Number 51-103180
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 0001825034-2019-02474, 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: associated device(s),: primary di#: primary di#: item#: 51-104160, item name: tprlc 133 t1 pps ho 16x152mm, lot number: 3817553, primary di#: 00880304491854.  item#: 51-104160, item name: tprlc 133 t1 pps ho 16x152mm, lot number: 6028661, primary di#: 00880304491854.  item#: 51-104140, item name: tprlc 133 t1 pps ho 14x148mm, lot number: 3817531, primary di#: 00880304491847.Item#: 51-103180, item name: tprlc 133 t1 pps so 18x156mm, lot number: 3975978, primary di#: 00880304498358.Item#: 51-103180, item name: tprlc 133 t1 pps so 18x156mm, lot number: 6022911, primary di#: 00880304498358.  item#: 51-103170, item name: tprlc 133 t1 pps so 17x154mm, lot number: 6238743, primary di#: 00880304498341.  item#: 51-103170, item name: tprlc 133 t1 pps so 17x154mm, lot number: 6133628, primary di#: 00880304498341.Item#: 51-103160, item name: tprlc 133 t1 pps so 16x152mm, lot number: 6309256, primary di#: 00880304489691.Item#: 51-103150, item name: tprlc 133 t1 pps so 15x150mm, lot number: 6118653, primary di#: 00880304491861.  item#: 51-103140, item name: tprlc 133 t1 pps so 14x148mm, lot number: 6075801, primary di#: 00880304491816.  item#: 51-103140, item name: tprlc 133 t1 pps so 14x148mm, lot number: 6170567, primary di#: 00880304491816.  item#: 51-103130, item name: tprlc 133 t1 pps so 13x146mmtp, lot number: 6308779, primary di#: 00880304489677.Item#: 51-103090, item name: tprlc 133 type1 pps so 9x137mm, lot number: 6462370, primary di#: 00880304498334.  item#: 51-100080, item name: tprlc 133 fp type1 pps so 8.0, lot number: 6364712, primary di#: 00-88030489660.Item#: 51-100060, item name: tprlc 133 fp type1 pps so 6.0, lot number: 6289409, primary di#: 00880304498174.Item#: 51-100060, item name: tprlc 133 fp type1 pps so 6.0, lot number: 6273744, primary di#: 00880304498174.Item#: 51-100050, item name: tprlc 133 fp type1 pps so 5.0, lot number: 6241443, primary di#: 00880304498167.Item#: 51-100040, item name: tprlc 133 fp type1 pps so 4.0, lot number: 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.
 
Manufacturer Narrative
It was determined this device did not cause or contribute to a reportable malfunction, serious injury, or adverse event.Please void this submission.
 
Event Description
It was determined this device did not cause or contribute to a reportable malfunction, serious injury, or adverse event.Please void this submission.
 
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Brand Name
TPRLC 133 T1 PPS SO 18X156MM
Type of Device
PROSTHESIS,HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8679053
MDR Text Key206968676
Report Number0001825034-2019-02473
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
K101086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 01/13/2020
1 Device was Involved in the Event
1 Patient was 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 Health Professional
Device Catalogue Number51-103180
Device Lot Number6022911
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/29/2019
Was the Report Sent to FDA? No
Date Manufacturer Received01/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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