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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS HO 17X154MM; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. TPRLC 133 T1 PPS HO 17X154MM; PROSTHESIS, HIP Back to Search Results
Catalog Number 51-104170
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/27/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Concomitant medical products: tprlc 133 t1 pps ho 12x144mm, cat#: 51-104120, lot#: 3727047.Tprlc133 mp t1 pps so 6x97.5mm, cat#: 51-108060, lot#: 2569203.Tprlc xr t1 pps 14x148mm, cat#: 51-105140, lot#: 2931353.Tprlc xr t1 pps 17x154mm, cat#: 51-105170, lot#: 2844723.Tprlc 133 t1 pps ho 13x146mm, cat#: 51-104130, lot#: 3714345.Tprlc 133 t1 pps so 15x150mm, cat#: 51-103150, lot#: 3262138.Tprlc 133 t1 pps so 15x150mm, cat#: 51-103150, lot#: 3386951.Tprlc xr t1 pps 16x152mm, cat#: 51-105160, lot#: 2990162.Tloc 133 mp sp t1 pps ho 6x97.5, cat#: 51-109060, lot#: 3433002.Tprlc 133 t1 pps ho 16x152mm, cat#: 51-104160, lot#: 3219007.Tprlc 133 t1 pps so 10x140mm, cat#: 51-103100, lot#: 3446079.Tprlc 133 fp type1 pps ho 7.0, cat#: 51-101070, lot#: 3354575.Tprlc xr t1 pps 15x150mm, cat#: 51-105150, lot#: 2867459.Tprlc 133 fp type1 pps ho 6.0, cat#: 51-101060, lot#: 2552323.Tprlc 133 t1 pps ho 15x150mm, cat#: 51-104150, lot#: 2563641.Report source: foreign country: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 00534, 0001825034 - 2020 - 00535, 0001825034 - 2020 - 00536, 0001825034 - 2020 - 00537, 0001825034 - 2020 - 00538, 0001825034 - 2020 - 00539, 0001825034 - 2020 - 00540, 0001825034 - 2020 - 00541, 0001825034 - 2020 - 00542, 0001825034 - 2020 - 00543, 0001825034 - 2020 - 00544, 0001825034 - 2020 - 00546, 0001825034 - 2020 - 00547, 0001825034 - 2020 - 00548, 0001825034 - 2020 - 00549.
 
Event Description
It was reported that debris was identified in sterile packages.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: b4, b5, d10, g4, h2, h3, h6 complaint sample was evaluated and the reported event was confirmed.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned products identified that there was debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier and black debris consistent with porous material from the device.Device history record (dhr) was reviewed and no discrepancies were found.Device history record (dhr) was reviewed and no discrepancies were found.These products were likely conforming when they left zimmer biomet control.The root cause of the reported issue is attributed to transit damage causing the foam packaging and porous material from device to become abraded and shed.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.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
TPRLC 133 T1 PPS HO 17X154MM
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9677169
MDR Text Key197599925
Report Number0001825034-2020-00545
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 company representative,foreig
Type of Report Initial,Followup
Report Date 06/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/20/2021
Device Catalogue Number51-104170
Device Lot Number2525467
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2020
Was the Report Sent to FDA? No
Date Manufacturer Received06/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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