MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA CEMENTED CRUCIATE RETAINING STANDARD FEMORAL COMPONENT LEFT SIZE 10; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration (4003)

Patient Problem Unspecified Infection (1930)

Event Date 03/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices - persona vivacit-e highly crosslinked polyethylene fixed bearing cruciate retaining articular surface left 10mm, catalog #: 42512000610, lot #: 63716003, persona cemented stemmed tibial component left size g, catalog #: 42532007901 lot #: 63670697.Report source - foreign: (b)(6).The complainant 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.Investigation incomplete.

Event Description

It is reported that the patient underwent a left knee arthroplasty revision to address instability.The surgeon did not have consent to properly correct the instability that was identified during the procedure, and the patient is scheduled to undergo an additional revision at a later date to fully address the instability.Revision operative notes identified that the femoral component was loose, but as no consent had been obtained from the patient, the femoral component was left in place and only the polyethylene component was replaced.

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.The following sections were updated: b4, g4, g7, h2, h3, h6, h10.The product was evaluated through manufacturing review and the reported event was confirmed through review of medical records.The device history records were reviewed and no discrepancies relevant to the reported event were identified.A definitive root cause could not be determined with the information 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: PERSONA CEMENTED CRUCIATE RETAINING STANDARD FEMORAL COMPONENT LEFT SIZE 10
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 8646681
• MDR Text Key: 146256744
• Report Number: 3007963827-2019-00164
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K172524
• 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: 12/03/2019

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 Model Number: N/A
• Device Catalogue Number: 42502606801
• Device Lot Number: 63765269
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 05/28/2019
• Supplement Dates Manufacturer Received: 11/26/2019
• Supplement Dates FDA Received: 12/03/2019
• 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: 104