MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA POSTERIOR STABILIZED ARTICULAR SURFACE LEFT 16MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Scar Tissue (2060); Joint Laxity (4526); Swelling/ Edema (4577)

Event Date 02/08/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - concomitant devices - persona revision cemented standard femoral component left size 5, catalog #: 42504605801, lot #: 64815371.Persona revision offset splined uncemented stem extension 3mm x 13mm x +135mm, catalog #: 42560313513, lot #: 64642627.Persona revision cemented tibial tray left size c, catalog #: 42542006401, lot #: 64334622.Persona revision offset splined uncemented stem extension 6mm x 12mm x +135mm, catalog #: 42560613512, lot #: 64783533.Persona revision central tibial cone, catalog #: 42545000508, lot #: 64643004.Persona revision cemented tibial augment half block left lateral size cd 10mm, catalog #: 42555803110, lot #: 64664285.Persona revision cemented tibial augment half block left lateral size cd 10mm, catalog #: 42555803110, lot #: 64661873.Unknown palacos bone cement.Medical records provided were reviewed by a health care professional and confirmed the reported event.The device history records were reviewed and no discrepancies 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.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2024-00976.

Event Description

It was reported that the patient underwent a left knee arthroplasty revision of the articular surface to address pain, instability, swelling and effusions approximately three (3) years following the patient's last knee procedure.During the revision, significant scar tissue was identified.The articular surface was exchanged for a larger size and the surgery was completed without complication.Initial operative notes noted no intraoperative complications.Revision operative notes noted that the patient was being revised for increasing global instability over the previous six (6) to nine (9) months.Upon examination, the patient had about five (5) degrees of recurvatum and significant instability at terminal extension with about one (1) centimeter of coronal plane instability.During the procedure, significant scar and fibrotic tissue was debrided.All implants were examined and appeared stable and the articular surface was replaced with a larger size with no intraoperative complications noted.

• Brand Name: PERSONA POSTERIOR STABILIZED ARTICULAR SURFACE LEFT 16MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18948830
• MDR Text Key: 338229814
• Report Number: 0001822565-2024-00975
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024237056
• UDI-Public: (01)00889024237056(17)220831(10)63756949
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 42512400416
• Device Lot Number: 63756949
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White