MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. GENDER SOLUTIONS ALL POLY PATELLA SIZE 0 8 MM THICKNESS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Muscle Weakness/Atrophy (1967); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Electrolyte Imbalance (2196); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a knee surgery and approximately 3 months post-op, the patient was diagnosed with patellar tendonitis and received a steroid injection.The patient continued to have ongoing issues with pain, swelling, quadricep weakness/atrophy, balance deficits, and limited range of motion.Additional courses of physical therapy were prescribed without resolution.The patient does not want to undergo another revision and has continued to seek help for ongoing symptoms.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 00585204025 - stem collar 25 mm o.D.For use with 16 mm or smaller diameter segmental stems - 64243673 5036964 - heraeus medical cement w/gent high viscocity - (b)(6) 183302 - vngd ssk psc intlk fmrl 60 rt - (b)(6) 183824 - vngd sskpsc tib brg s 14x63/67 - (b)(6) 185201 - bmt 360 tib tray 63mm - (b)(6) 148162 - bmt gb knee stm 12x80 - (b)(6) 130615 - intramedullary plug xl - (b)(6).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Office notes post-surgery state patient still has pain, swelling and range of motion issues.Patient is also experiencing knee weakness which has limited her functional mobility.A definitive root cause cannot be determined.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: GENDER SOLUTIONS ALL POLY PATELLA SIZE 0 8 MM THICKNESS
• 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: 20796436
• Report Number: 0002648920-2024-00363
• Device Sequence Number: 20785690
• Product Code: JWH
• UDI-Device Identifier: 00889024189584
• UDI-Public: (01)00889024189584(17)231031(10)64212622
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/26/2024

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: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00542000800
• Device Lot Number: 64212622
• 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: 11/26/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2018
• 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 H11.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 69 KG