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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 TYPE1 PPS SO 17.0 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TPRLC 133 TYPE1 PPS SO 17.0 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 12/04/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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. Concomitant medical products: 51-105110, stem, lot # 3560785. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 11472.
 
Event Description
It was reported that upon inspection, the devices were found have debris inside the sterile packaging, as well as staining on the packaging. Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Medical device: udi (b)(4). Report source: foreign source- (b)(6). Complaint sample was evaluated and the reported event was confirmed. The visual inspection of the returned products identified that foam inserts were damaged and there was poly debris. Dhr was reviewed and no discrepancies were found. Review of complaints history search for this part number identified no other complaints reported for the same lot. The root cause of the reported event is likely to be due to transit damage causing the foam to shed. This product falls within the scope of corrective action that is reviewing the packaging configurations at zimmer biomet, (b)(4). 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 NameTPRLC 133 TYPE1 PPS SO 17.0
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8195739
MDR Text Key131384640
Report Number0001825034-2018-11471
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K101086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 07/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number51-103170
Device Lot Number3795964
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2019
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/09/2019
Is This a Reprocessed and Reused Single-Use Device? No

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