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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SEGMENTAL POLYETHYLENE INSERT PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. SEGMENTAL POLYETHYLENE INSERT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Fall (1848); Fever (1858); Unspecified Infection (1930); Rash (2033); Staphylococcus Aureus (2058); Swelling (2091); Discharge (2225); Ambulation Difficulties (2544)
Event Date 02/16/2018
Event Type  Injury  
Manufacturer Narrative
Cmp-(b)(4). Concomitant medical products: segmental articular surface, catalog #: 00585003014, lot #: 62788895. Report source: (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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-01479. Product location unknown.
 
Event Description
It was reported that the patient presented with swelling, discharge, fever and had reported recent falls. The patient was then revised to address an infection. Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
Reported event was confirmed by review of medical records and analysis of returned device. The poly components showed minimal signs of wear. Measured dimensions were conforming to print specification. Device history record (dhr) was reviewed and no discrepancies 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. Additional reports have been submitted for this event. Please see reports: 0001822565 - 2019 - 00964, 0001822565 - 2019 - 00965.
 
Event Description
No further event information available at the time of this report.
 
Event Description
It was further reported through patient's medical records that the patient was noted to have pji and haemarthrosis which was likely haematologically seeded. Patient also reported to have itchy macular rash. Furthermore, the pus culture was positive for multisensitive staph aureus and therefore, the patient was started on antibiotics. Finally, it was noted the patient is using a cane to ambulate.
 
Manufacturer Narrative
Concomitant medical products: stem collar 35 mm o. D. , catalog #: 00585204035 lot #: 63284526. Tibial component precoat size 2, catalog #: 00588000200 lot #: 63696269tibial block and screws precoat size 2 5 mm thickness, catalog #: 00598800226 lot #: 63168114. Stem extension straight 11mm dia x 100mm length, catalog #: 00598801011 lot #: 63451500. Palacos r+g 1x40, catalog #: 66022663 lot #: 86604591. Fluted stem extension straight precoat, catalog #: 00585205011 lot #: 63574485. Distal femoral component, catalog #: 00585001301 lot #: 63588147. Tibial block and screws precoat size 2. 5 mm, catalog #: 00598800226 lot #: 63281479. Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
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Brand NameSEGMENTAL POLYETHYLENE INSERT
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7342141
MDR Text Key102513364
Report Number0001822565-2018-01480
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
PK070978
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 02/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number00585001395
Device Lot Number63649607
Other Device ID Number00889024195660
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 03/15/2018 Patient Sequence Number: 1
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