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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HA TPRLOC POR LAT FML 13.5X147 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. HA TPRLOC POR LAT FML 13.5X147 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Material Erosion (1214); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Local Reaction (2035)
Event Date 07/25/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: femoral head, catalog#: 650-0840, lot#: 2686076; acetabular shell, catalog#: 00620205820, lot#: 62585810; acetabular liner, catalog#: 00631005836, lot#: 62692445; bone screw, catalog#: 00625006540, lot#: 61126043; bone screw, catalog#: 00625006550, lot#: 60376941 & 60809033; bone screw ,catalog#: 00625006525, lot#: 61953465; bone screw, catalog#: 00625006530, lot#: 62483015. Reporting source: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that a patient was revised due to pain, metallosis observed and black wear debris observed around head/ neck trunnion. White/cream fluid around head/ neck trunnion that was not observed to be pus. Joint and patient showed no symptoms of infection.
 
Manufacturer Narrative
(b)(4). Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Root cause was unable to be determined. 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 NameHA TPRLOC POR LAT FML 13.5X147
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8912334
MDR Text Key154943487
Report Number0001825034-2019-03718
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
K030055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 10/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2018
Device Model NumberN/A
Device Catalogue Number21-123207
Device Lot Number212040
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 08/20/2019 Patient Sequence Number: 1
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