MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Thrombosis (2100)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: tibia cemented; p/n: 42532007902, l/n: 64019716; femur cemented; p/n: 42500606802, l/n: 63740573; articular surface fixed; p/n: 42522601012, l/n: 63512474; stem extension cemented; p/n: 42557000114, l/n: 63512474; all-poly patella cemented; p/n: 42540200038, l/n: 63761686.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to it remains implanted the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 06229, 3007963827 - 2018 - 00194, 0001822565 - 2018 - 06230.Remains implanted.

Event Description

It was reported a patient underwent initial total right knee arthroplasty two months post-implantation.Subsequently, the patient experience's a blood clot.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Updated: a5, b4, b5, d11, g4, g7 additional: h1, h2, h6, h10 d11 medical products: tibia cemented; p/n: 42532007902, l/n: 64019716; femur cemented; p/n: 42500606802, l/n: 63740573; articular surface fixed; p/n: 42522601012, l/n: 63512474; stem extension cemented; p/n: 42557000114, l/n: 63927891; all-poly patella cemented; p/n: 42540200038, l/n: 63761686; hex head screw; p/n: 00590103533, l/n: 63883463.Complaint sample was evaluated via medical records and the reported event was confirmed.Medical records were provided and reviewed by a health care professional.Review of the available records identified no complications during the primary surgery.Office notes identified the patient developed a postoperative blood clot within 2 months of the right tka.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 03350, 0001822565 - 2019 - 03351.

Event Description

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

• Brand Name: ARTICULAR SURFACE FIXED BEARING
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8046946
• MDR Text Key: 126410102
• Report Number: 0001822565-2018-06229
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K123459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 42522601012
• Device Lot Number: 63512474
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR
• Patient Weight: 93