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

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Unstable (1667)

Patient Problem Pain (1994)

Event Date 02/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: nexgen rotating hinge tibial plate, catalog # 00588000500 lot # 63979163; nexgen stems, catalog # 00598801514, lot # 63869669; nexgen stems, catalog # 00598801018, lot # 63843833; nexgen rotating hinge articular surface 00588006014, catalog # 00588006014, lot # 63686746.Report source: (b)(6).Customer has indicated that the product will not be returned because it is not returned by patient.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2019-01120, 0002648920-2019-00194, 0002648920-2019-00195, 0001822565-2019-01123.Not returned by patient.

Event Description

It was reported that the patient underwent a knee arthroplasty.The patient was experiencing pain and instability six months post operative.Subsequently, the patient was revised due to loosening.

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.Dhr was reviewed and no discrepancies relevant to the reported event were found.Per package insert: pain, instability, and loosening are known adverse effect of this procedure.However, a definitive root cause cannot 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: NEXGEN ROTATING KNEE FEMORAL COMPONENT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8416284
• MDR Text Key: 138656575
• Report Number: 0001822565-2019-01121
• 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: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00588001602
• Device Lot Number: 63333748
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2019
• 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: 54 YR
• Patient Weight: 150