MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA ARTICULAR SURFACE FIXED BEARING (PS); PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544); Subluxation (4525); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 42500006401 - femur cemented posterior stabilized (ps) narrow left size 8 - 63193676.42532006401 - tibia cemented 5 degree stemmed left size c - 63380431.42557000114 - stem extension tapered cemented 14 mm diameter +30 mm length - 63483656.42540200029 - all-poly patella cemented 29 mm diameter - 63411320.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial left total knee arthroplasty.Patient reported a popping sensation with feeling the joint gave out.They noted their last episode they heard the pop and felt the implant move out then pop into place.The patient also reported having pain and difficulty ambulating.No records were provided.The patient followed up with their surgeon, who ordered an mri for their continued pain, difficulty ambulating, decreased range of motion, and subluxation.A revision was planned for the near future but was delayed due to the patient's medical history.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; b6; d2; g1; g3; g6; h1; h2; h11 the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following; 6 months of popping occurring making the patient feel unstable and also has some back pathology at this time.The patient has pain at rest and with activities affecting ambulation, instability, buckling, and popping.The exam noted effusion, tenderness, decreased rom, and an antalgic gait using a cane.X-ray imaging noted a well aligned prosthesis with anterior subluxation of tibia in the lateral view and a mri was ordered.Treatment was discussed and a revision was put on hold due to pre-existing medical conditions.This event is for a planned revision for instability, subluxation, difficulty ambulating, and pain is considered a serious injury as illness or impairment for which hospitalization, medical intervention and/or surgical intervention has occurred.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: intact left knee arthroplasty.Trace joint effusion.Mild extensor mechanism tendinosis, with patella baja.No soft tissue mass is visualized.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: PERSONA ARTICULAR SURFACE FIXED BEARING (PS)
• Common Device Name: 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: 19461968
• Report Number: 0001822565-2024-01869
• Device Sequence Number: 17826280
• Product Code: MBH
• UDI-Device Identifier: 00889024237117
• UDI-Public: (01)00889024237117(17)201031(10)63202750
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 42512400513
• Device Lot Number: 63202750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 06/11/2024; 09/25/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 06/20/2024; 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 88 KG