MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL TIBIAL CEMENTED SIZE E LEFT MEDIAL; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Product location unknown.

Event Description

It was reported that the patient underwent initial knee arthroplasty on an unknown date.Subsequently, the patient suffered a non-displaced tibial plateau fracture one month post-operatively which was treated conservatively and healed.The x-ray showed that the bone was crushed.No corner pin was used.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).Udi : (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.

Manufacturer Narrative

(b)(4).Reported event is considered confirmed as review of the x-ray review from mmi states that there was a periprosthetic fracture of the medial tibial plateau.Also, there are radiolucent lines at the tibial tray component metal-bone interface laterally (zone 5) and anteriorly, consistent with loosening of the tibial tray component.Device history record was reviewed and no discrepancies relevant to the reported event were found.An x-ray review showed that the bone quality is shown as osteopenic.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.

• Brand Name: PARTIAL TIBIAL CEMENTED SIZE E LEFT MEDIAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7515142
• MDR Text Key: 108286910
• Report Number: 0001825034-2018-03375
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 42538000501
• Device Lot Number: 63661672
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 01/02/2019; 01/04/2019
• Supplement Dates FDA Received: 01/03/2019; 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR