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

Catalog Number 42538000301

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

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Our investigation is ongoing.A follow-up/final report will be submitted when additional information becomes available.Location of the device is unknown.

Event Description

It was reported that the patient underwent an initial knee arthroplasty.The patient experienced pain.It was discovered the patient's tibial bone fractured and she was then revised a month later.

Manufacturer Narrative

Udi- (b)(4).Reported event was confirmed by review of x-ray.Review of x-ray review report states unicompartmental knee arthroplasty with periprosthetic fracture and depression of the tibial plateau at the site of the arthroplasty/fracture.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 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 C LEFT MEDIAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7778604
• MDR Text Key: 116954344
• Report Number: 0001825034-2018-04866
• 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: 04/30/2019

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: 42538000301
• Device Lot Number: 63807402
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2019
• 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: 62 YR
• Patient Weight: 61