MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL TIBIAL CEMENTED SIZE E RIGHT 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 Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 42558000502 2927364512711 partial femur cemented size 5 right medial.42528200510 2412164354353 partial articular surface right medial size e 10 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 right partial knee arhtroplasty.Subsequently, patient experienced tibial head fracture after ppk.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays received.X-ray evaluation report confirms medial tibial plateau fracture with subtle increased periprosthetic lucency, and minimal tibial implant change in position.Bone quality appears osteopenic.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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

It was reported patient underwent right partial knee arthroplasty.Subsequently, the patient was revised approximately one year post implantation due to medial tibial plateau fracture.Additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays received.X-rays evaluation report provided by third party confirms medial tibial plateau fracture with subtle increased periprosthetic lucency and minimal tibial implant change in position.Bone quality appears osteopenic.Post-operative x-ray suggested no evidence of fractures and the implants were in the correct axial position.Primary operative notes do not suggest any intra operative complications.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.This will be reported under mfr number 0001825034-2021-00295.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable.This will be reported under mfr number 0001825034-2021-00295.

• Brand Name: PARTIAL TIBIAL CEMENTED SIZE E RIGHT MEDIAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10359325
• MDR Text Key: 201550011
• Report Number: 0001822565-2020-02755
• 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: 01/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42538000502
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Other
• Patient Weight: 75