MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION TIBIAL CENTRAL CONE SIZE X-SMALL; 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); Bursitis (4832)
Date of Event	09/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona revision tibia fixed cemented left size f catalog #: 42542007501 lot #: 64334587, persona revision stem extension 6mm offset splined uncemented 15mm x +135mm catalog #: 42560613515 lot #: 64523137, persona revision tibial augment cemented half block left lateral size ef 10mm catalog #: 42555805110 lot #: 64453282, persona revision tibial augment cemented half block left medial size ef 10mm catalog #: 42555805310 lot #: 64352568, persona revision femur cemented plus left size 9+ catalog #: 42504606611 lot #: 64288155, persona revision stem extension 6mm offset splined uncemented 17mm x 135+mm catalog #: 42560613517 lot #: 64542501, persona revision femoral central cone size small catalog #: 42545001011 lot #: 64470408, persona revision femoral distal augment cemented size 9, 9+ 5mm catalog #: 42556606605 lot #: 64345779, refobacin bone cement r 1x40 us catalog #: 110034355 lot #: 849abh1703, refobacin bone cement r 1x40 us catalog #: 110034355 lot #: 849abh1703, refobacin bone cement r 1x40 us catalog #: 110034355 lot #: 839haa0807, refobacin bone cement r 1x40 us catalog #: 110034355 lot #: 849bah1404.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.
Event or Problem Description
It was reported that the patient experienced pes bursitis, pain, throbbing, cramping and tightness approximately four (4) years following left knee arthroplasty.The patient was prescribed meloxicam and given a cortisone injection as well as topical pain therapies.Initial operative notes noted the patient's tibial bone was quite sclerotic from an unknown previous procedure and several small drill holes were made to help with cement interdigitation; however, no intraoperative complications were noted.No additional patient consequences were reported.
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 reported event was confirmed through review of medical records.The device history records were not reviewed as the event was determined to be unrelated to the implanted device.Bursitis is the inflammation or irritation of the bursae (the fluid filled sac that cushions the joint) and is typically caused by repetitive motion, overuse, and pressure to the bursae.Bursitis is a very common condition that can impact any of the joints and can last for a short duration or years.Symptoms the patient can experience include pain, tenderness, swelling, stiffness, decrease in movement, and/or redness at or around the joint that is involved.Conservative treatment consists of over the counter (otc) medications such as pain relievers and anti-inflammatories, rest, ice, elevation, and applying pressure wraps.If conservative treatments fail, physical therapy, aspiration, arthroscopy, or steroid injections may be necessary.The complaint indicates that post-operative bursitis developed and required medical intervention for treatment.The root cause was determined to be traced to non-device related factors.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 REVISION TIBIAL CENTRAL CONE SIZE X-SMALL
• 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: 20235537
• Report Number: 0001822565-2024-02970
• Device Sequence Number: 15494684
• Product Code: JWH
• UDI-Device Identifier: 00889024560666
• UDI-Public: (01)00889024560666(17)290831(10)64470026
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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 Model Number: N/A
• Device Catalogue Number: 42545000510
• Device Lot Number: 64470026
• 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: 08/27/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2019
• 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 H11 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American