MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA ALL-POLY PATELLA CEMENTED 29 MM DIA; 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	08/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer 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.Additional associated products: 42504605802 persona femur cemented standard right size 5 lot# 64890399.42560007514 persona stem extension tapered cemented 14 mm dia +75mm l lot# 65042512.42542006702 persona tibia fixed cemented right size d lot# 64960944.42522800410 persona articular surface fixed bearing (cck) right 10mm lot# 64751747.42560007514 persona stem extension tapered cemented 14 mm dia +75mm l lot# 65042512.00590103548 hex head screw 3.5mm x 48mm lot# 64709940.Unk stryker cement x 4.
Event or Problem Description
It was reported a patient had an initial right total knee arthroplasty followed by a revision 7 years later due to aseptic loosening.Subsequently, the patient began to experience pain over the pes bursa and was initial prescribed nsaids and physical therapy for pes anserinus bursitis.The patient received a cortisone injection sixteen months post revision.All implants remain in place and at the two-year follow-up, reports no pain.
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.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 antiinflammatories, 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: PERSONA ALL-POLY PATELLA CEMENTED 29 MM DIA
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19139781
• Report Number: 0002648920-2024-00111
• Device Sequence Number: 20948330
• Product Code: JWH
• UDI-Device Identifier: 00889024247680
• UDI-Public: (01)00889024247680(17)251202(10)64843582
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 08/06/2024

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: 12/02/2025
• Device Model Number: N/A
• Device Catalogue Number: 42540200029
• Device Lot Number: 64843582
• 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: 03/28/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2021
• 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: Required Intervention
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White