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

Model Number N/A

Device Problem Noise, Audible (3273)

Patient Problems Swelling (2091); Limited Mobility Of The Implanted Joint (2671)

Event Date 07/15/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog #: 42500606802, femur cemented posterior stabilized, lot # 62291568, catalog #: 42532007502, tibia cemented 5 degree stemmed, lot # 62416680, catalog #: 42540000038, all poly patella cemented, lot # 62435814.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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: 3007963827-2019-00035.Remains implanted.

Event Description

It was reported that patient had clicking and vise-grip feeling on the right knee.Doctor states the relation to the device is not related.Treatment included exercise on bicycle.

Event Description

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

Manufacturer Narrative

(b)(4).Reported event was consider confirmed via the provided medical records confirming the patient's ailments.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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.

• Brand Name: ARTICULAR SURFACE FIXED BEARING CONSTRAINED POSTERIOR STABILIZED
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8315665
• MDR Text Key: 135378778
• Report Number: 0001822565-2019-00512
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: K123459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/09/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 42522600810
• Device Lot Number: 62294445
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2019
• Initial Date FDA Received: 02/07/2019
• Supplement Dates Manufacturer Received: 10/07/2019
• Supplement Dates FDA Received: 10/10/2019
• 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: 65