MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TRABECULAR METAL CRUCIATE RETAINING FEMORAL COMPONENT SIZE 9 RIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 04/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant devices: persona vivacit-e medial concgruent articular surface 11mm right, catalog #: 42522100811, lot #: 63179254, persona cemented stemmed tibial component size f right, catalog #: 42532007502, lot #: 64293488.Report source - foreign: (b)(6).The complainant has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all report associated with this event: 0001822565-2020-01818.Investigation incomplete.

Event Description

It is reported that the patient underwent a right knee arthroplasty revision to address pain, potential dislocation and noise from the right knee joint one (1) week post-operatively.During the procedure, only the articular surface was removed and replaced.The dislocation could not be confirmed, however, the surgeon reported feeling a scratch when moving the implants from extension to flexion.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 following sections were updated: b4, g4, g7, h2, h3, h6, h10.The product was evaluated through manufacturing review, however, the reported dislocation could not be confirmed.The device history records were reviewed and no discrepancies were identified.Per the persona knee package insert, pain and dislocation are known potential adverse effects of knee arthroplasty.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 TRABECULAR METAL CRUCIATE RETAINING FEMORAL COMPONENT SIZE 9 RIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10082209
• MDR Text Key: 191805984
• Report Number: 0001822565-2020-01819
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 008809024230804
• UDI-Public: (01)008809024230804
• 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: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• 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: 42502806602
• Device Lot Number: 64400418
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention