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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONTINUUM TRILOGY ELEVATED RIM POLYETHYLENE LINER; PROSTHESIS, HIP

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ZIMMER BIOMET, INC. CONTINUUM TRILOGY ELEVATED RIM POLYETHYLENE LINER; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/09/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Product location unknown.
 
Event Description
It was reported that a hair was found inside the sterile packaging.The surgery was completed with another insert.
 
Manufacturer Narrative
(b)(4).Reported event was considered confirmed per a picture that showed a black fiber hair-like substance on the liner.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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
CONTINUUM TRILOGY ELEVATED RIM POLYETHYLENE LINER
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7568486
MDR Text Key110037948
Report Number0001822565-2018-03023
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
PMA/PMN Number
PK151448
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 04/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date08/31/2022
Device Model NumberN/A
Device Catalogue Number00875200832
Device Lot Number63754726
Other Device ID Number00889024149670
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/09/2018
Initial Date FDA Received06/05/2018
Supplement Dates Manufacturer Received04/04/2019
Supplement Dates FDA Received04/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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