MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ROTATING HINGE KNEE FEMORAL COMPONENT; KNEE PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Tissue Damage (2104)

Event Date 05/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: nexgen stem extension catalog # 00598801215 lot # 62382612.Nexgen stem extension catalog # 00598801215 lot # 62448487.Nexgen headed screw catalog # 00579104100 lot # 62322511.Nexgen headed screw catalog # 00579104100 lot # 62293341.Rotating hinge tibial plate catalog # 00588000500 lot # 62382473.Rotating hinge articular surface catalog # 00588006012 lot # 62384946.Report source: foreign: (b)(6).Customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0002648920-2019-00049, 0002648920-2019-00050, 0001822565-2019-00294, 0001822565-2019-00295, 0001822565-2019-00296, 0001822565-2019-00297.Product location is unknown.

Event Description

It was reported that the patient underwent an initial knee arthroplasty.Subsequently, the patient was revised due to soft tissue deficit.

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 unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: ROTATING HINGE KNEE FEMORAL COMPONENT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8268015
• MDR Text Key: 133764626
• Report Number: 0001822565-2019-00298
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K013385
• 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: 10/12/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00588001602
• Device Lot Number: 11010060
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 01/22/2019
• Supplement Dates Manufacturer Received: 10/07/2019
• Supplement Dates FDA Received: 10/14/2019
• 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 Weight: 81