MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION CEMENTED FIXED TIBIAL TRAY LEFT SIZE F; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Muscle/Tendon Damage (4532); Swelling/ Edema (4577); Bursitis (4832)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient required additional physical therapy and was prescribed diclofenac and celebrex for treatment of pes anserinus bursitis, iliotibial band tendonitis, pain, swelling, stiffness, weakness and instability approximately two (2) months following left knee arthroplasty.Initial operative notes noted no intraoperative complications upon implantation of devices.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona revision offset splined uncemented stem extension 3mm x 13mm x +135mm catalog #: 42560313513 lot #: 64799465, persona revision tibial central cone size medium catalog #: 42545000512 lot #: 64643018, persona revision cemented femoral component plus left size 9+ catalog #: 42504606611 lot #: 64857996, persona revision cemented distal femoral augment size 9, 9+ 5mm catalog #: 42556606605 lot #: 64882498, persona revision cemented distal femoral augment size 9, 9+ 5mm catalog #: 42556606605 lot #: 64799265, persona revision cemented distal femoral augment size 9, 9+ 5mm catalog #: 42556606605 lot #: 64769986, persona revision constrained condylar knee left 16mm catalog #: 42512800716 lot #: 64615633, persona revision offset splined uncemented stem extension 6mm x 18mm x +135mm catalog #: 42560613518 lot #: 64769916, refobacin bone cement r 1x40 us catalog #: 110034355 lot #: 942aaa2510, refobacin bone cement r 1x40 us catalog #: 110034355 lot #: 942aaa2510, refobacin bone cement r 1x40 us catalog #: 110034355 lot #: 936bae2505.The device history records were not reviewed as the reported event was not related to the zimmer biomet 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 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.Tendonitis is the inflammation or irritation of the tendons and is typically caused by repetitive motion, overuse and pressure to the bursae.Symptoms the patient can experience include pain, tenderness, swelling, stiffness, decrease in movement, and/or redness at or around the joint that is involved.This can impact the patients¿ ability to use the joint to its full potential.Patients can experience a decrease with overall activities of daily living, range of motion of the joint, decrease in quality of life, as well as increasing the need for possible over the counter (otc) medications for swelling and pain control.Treatment for tendonitis can consist of otc medications, such as tylenol and anti-inflammatories, prescribed pain medications, physical therapy, rest, ice, elevating the affected joint and steroid injections.Based on the information provided, the root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device.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: 0001822565-2024-00685, 0001822565-2024-00686.H3 other text : event unrelated to zimmer biomet product.

• Brand Name: PERSONA REVISION CEMENTED FIXED TIBIAL TRAY LEFT SIZE F
• 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: 18825774
• Report Number: 0001822565-2024-00684
• Device Sequence Number: 7720814
• Product Code: JWH
• UDI-Device Identifier: 00889024562806
• UDI-Public: (01)00889024562806(17)300228(10)64599642
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2024

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 Model Number: N/A
• Device Catalogue Number: 42542007501
• Device Lot Number: 64599642
• 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: 02/09/2024
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 128 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White