MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIAL AUGMENT CEMENTED HALF BLOCK RIGHT LATERAL; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bursitis (4832)
Date of Event	10/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 42542008302 - tibia fixed cemented right size h stem extension use required - 64207435.42560313522 - stem extension 3mm offset splined uncemented 22 mm diameter +135 mm length - 64523129.42555807410 - tibial augment cemented half block right medial size gh 10 mm thickness - 64352296.42522801014 - articular surface fixed bearing constrained condylar knee (cck) right 14 mm height use with tibia sizes g, h / revision femur sizes 11, 11+, 13 with l - 64305432.42504607002 - femur cemented standard right size 11 - 64500460.42560313524 - stem extension 3mm offset splined uncemented 24 mm diameter +135 mm length - 64536735 42556807010 - femoral posterior augment cemented size 11, 11+ 10 mm thickness - 64340801 42556807005 - femoral posterior augment cemented size 11, 11+ 5 mm thickness - 64363727 184704 - series a pat w/wr std 31 1 peg - 910590 110034355 - refobacin bc r 1x40 us - 828bad1611.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 a patient had underwent a knee surgery and was doing well until experiencing mild pes anserine bursitis 5 years post-op.The patient was given a cortisone injection.No further information has been provided.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; d2; g1; g3; g6; h1; h2; h3; h6; h10.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 postop bursitis developed and required medical intervention for treatment.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.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
It was further reported that the patient was given cortisone injections twice.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 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.
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.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Root cause of the reported event is not device related.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 TIBIAL AUGMENT CEMENTED HALF BLOCK RIGHT LATERAL
• 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: 20579753
• Report Number: 0001822565-2024-03451
• Device Sequence Number: 20856873
• Product Code: JWH
• UDI-Device Identifier: 00889024557413
• UDI-Public: (01)00889024557413(17)290331(10)64333017
• 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: 2019
• 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,Followup,Followup
• Report Date (Section B): 06/11/2025

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: 42555807210
• Device Lot Number: 64333017
• 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: 10/14/2024
• Supplement Date Received by Manufacturer: 10/31/2024; 05/08/2025; 05/28/2025
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 11/04/2024; 05/21/2025; 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 125 KG
• Patient Race: Black Or African American