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

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.

• Brand Name: SEGMENTAL POLYETHYLENE INSERT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7342141
• MDR Text Key: 102513364
• Report Number: 0001822565-2018-01480
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: PK070978
• Number of Events Reported: 1
• 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 Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00585001395
• Device Lot Number: 63649607
• Other Device ID Number: 00889024195660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR