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

Catalog Number 42538000402

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: partial cemented femur, catalog # 42558000302, lot # 63963114; partial articular surface, catalog # 42528200410, lot # 63837538.(b)(6).Once the investigation has been completed, a follow-up mdr will be submitted.Remains implanted.

Event Description

It was reported a week post implantation, the patient's tibial bone fractured.The surgeon went in and performed a plate fixation.Attempts have been made and additional information on the reported event is unavailable.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of radiographs.Review of the x-rays confirmed the reported issue of tibial bone fracture and identified that the tibial tray had subsided.On the second image there is flattening of the medial femoral condyle with surrounding sclerosis as well as cortical irregularity suggesting an impaction type fracture.Overall fit and alignment of the implants is appropriate.Osteopenia is present.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.

Event Description

No further event information available at the time of this report.

• Brand Name: PARTIAL TIBIAL CEMENTED SIZE D RIGHT MEDIAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7777980
• MDR Text Key: 116933228
• Report Number: 0001825034-2018-04615
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: PK161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 42538000402
• Device Lot Number: 63728280
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 50