MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION OFFSET SPLINED UNCEMENTED STEM EXTENSION 3MM X 13MM X +135MM; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Muscle Weakness (1967); Muscle/Tendon Damage (4532); Swelling/ Edema (4577)

Event Type  Injury  

Event 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.

Manufacturer Narrative

(b)(4).D10 - concomitant devices - persona revision cemented fixed tibial tray left size f, catalog #: 42542007501, lot #: 64599642.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: 0001822565-2024-00684 and 0001822565-2024-00686.H3 other text : event unrelated to zimmer biomet product.

• Brand Name: PERSONA REVISION OFFSET SPLINED UNCEMENTED STEM EXTENSION 3MM X 13MM X +135MM
• 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: 18825791
• MDR Text Key: 336771586
• Report Number: 0001822565-2024-00685
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00887868250033
• UDI-Public: (01)00887868250033(17)300805(10)64799465
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191625
• 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: 03/04/2024

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42560313513
• Device Lot Number: 64799465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2020
• 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): Required Intervention
• Patient Sex: Female
• Patient Weight: 128 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White