MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SEGMENTAL DISTAL FEMORAL COMPONENT; PROSTHESIS KNEE

Model Number N/A

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/23/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: segmental polyethylene insert catalog # 00585001295 lot # 62271451; segmental articular surface catalog # 00585002012 lot # 62949396; segmental fluted stem extension straight precoat catalog # 00585205014 lot # 62032778.Stem collar 25 mm o.D.For use with 16 mm or smaller diameter segmental stems catalog # 00585204025 lot # 61960736.Report source: (b)(6).Customer has indicated that the product will not be returned because it was discarded.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: 0001822565-2021-01605.Discarded.

Event Description

It was reported that the patient underwent a revision due to loosening.The surgeon removed existing implants and replaced with new.Attempt for further information has been made, but no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Visual evaluation of the provided pictures shows the products had been explanted.Foreign material remains on the stem component.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.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: SEGMENTAL DISTAL FEMORAL COMPONENT
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11975138
• MDR Text Key: 255399637
• Report Number: 0001822565-2021-01602
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K070978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00585001202
• Device Lot Number: 62978969
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2021
• 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