MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL KNEE NONPOROUS STEMMED TIBIAL BASEPLATE SIZE 1; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	10/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 : 00541401402 - gender solutions female (gsf) femoral component nonporous size 1, right - 64231690.00542802109 - articular surface ultracongruent size 1 2 right 9 mm height - 64145945.00542000800 - all poly patella size 0 8 mm thickness - 64212622.00111314001 - palacos rg 1x40 single - 86444599.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 had an initial right total knee arthroplasty.Approximately one year post-op, the patient was experienced ongoing quadricep muscle weakness and atrophy, pain, stiffness, limited range of motion, and instability.The patient underwent additional courses of physical therapy without relief.Subsequently, the patient was revised.The intra-op tissue sample displayed fibroconnective tissue and reactive synovium with fibrosis.All components were revised except the patella.Attempts have been made and all available information has been provided.
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.No devices or photographs of devices were received; therefore, the condition of the components is unknown.Photograph of patient's swollen knee was provided.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Primary operative notes suggest no intraoperative complications.Office notes post-surgery state patient has pain, swelling, stiffness and range of motion issues.Patient has sense of instability due to the weakness during ambulation.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: NATURAL KNEE NONPOROUS STEMMED TIBIAL BASEPLATE SIZE 1
• 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: 19575474
• Report Number: 0001822565-2024-02081
• Device Sequence Number: 3980218
• Product Code: JWH
• UDI-Device Identifier: 00889024258730
• UDI-Public: (01)00889024258730(17)270331(10)63943727
• 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
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

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: 630701210
• Device Lot Number: 63943727
• 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: 05/31/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2018
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 69 KG