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

Model Number N/A

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

Patient Problem Bone Fracture(s) (1870)

Event Date 03/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 42558000401 29273645127 partial femur cemented size 4 left medial.42518200608 2324364123 partial articular surface left medial size f 8 mm thickness.Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent left partial knee arthroplasty.Subsequently, patient experienced tibial head fracture after ppk, doctor suspects no defects in the implants.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected : updated:b3, d4; h4.

Event Description

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

Event Description

It was reported patient underwent initial left partial knee arthroplasty.Subsequently, the patient was revised on unknown date due tibial periprosthetic fracture.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated:h2; h3; h6 reported event was confirmed by review of x-rays received.X-rays were provided and reviewed by a health care professional.Review found unicompartmental arthroplasty with comminuted and depressed periprosthetic fracture of the medial compartment.Mild depression of the fracture noted.Bone quality appears normal.Fit and alignment appear normal.No signs of loosening or radiolucency.Post revision surgery image demonstrates normal integration of newly placed hardware/cement.The 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 report 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 F LEFT MEDIAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10359329
• MDR Text Key: 201544478
• Report Number: 0001822565-2020-02751
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/11/2020

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42538000601
• Device Lot Number: 64119414
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/03/2020
• Supplement Dates Manufacturer Received: 08/05/2020; 09/23/2020; 11/09/2020
• Supplement Dates FDA Received: 08/13/2020; 10/14/2020; 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 138