MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ULTRACONGRUENT FIXED BEARING ARTICULAR SURFACE 12MM LEFT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products- unknown persona tibial component catalog #: ni lot #: ni, unknown persona femoral component catalog #: ni lot #: ni.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Investigation incomplete.

Event Description

It was reported the patient underwent a knee arthroplasty revision to address instability and pain approximately one (1) year and four (4) months post-operatively.It was additionally reported that the cause of instability was not identified intraoperatively, however, the patient was noted to be infected.Attempts have been made and no additional information is available at this time.

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 reported event was unable to be confirmed due to limited information received from the reporter.No product, photos, or medical records were provided.Review of the device history records identified no deviations or anomalies during manufacturing.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.

• Brand Name: PERSONA ULTRACONGRUENT FIXED BEARING ARTICULAR SURFACE 12MM LEFT
• 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: 9377578
• MDR Text Key: 168053617
• Report Number: 3007963827-2019-00331
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K121771
• 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: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 42512200512
• Device Lot Number: 63727388
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2020
• 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