MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA PARTIAL TIBIAL CEMENTED SIZE F RIGHT MEDIAL; 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	11/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 42558000402 - partial femur cemented size 4 right medial - 65469579.42528200610 - partial articular surface right medial size f 10 mm thickness - 65805450.110035368 - biomet bc r 1x40 us - ax28ce1901.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial right unilateral knee arthroplasty.Subsequently 5 months post-op, the patient received a steroid injection to the right knee for pes bursitis following an incident of pain after bending down to get into a plank position.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.

• Brand Name: PERSONA PARTIAL TIBIAL CEMENTED SIZE F RIGHT MEDIAL
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19351262
• Report Number: 3007963827-2024-00183
• Device Sequence Number: 7298546
• Product Code: HSX
• UDI-Device Identifier: 00880304812710
• UDI-Public: (01)00880304812710(17)320921(10)65475206
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 09/03/2024

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: 42538000602
• Device Lot Number: 65475206
• 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: 04/24/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2022
• 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 H10.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Race: White