MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING CONSTRAINED CONDYLAR KNEE (CCK); 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); Synovitis (2094)
Date of Event	09/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient is experiencing pain and diagnosed with synovitis three months post implantation.It was noted that there was a complex primary tka utilizing revision components with stems and semi constrained liner, mac plus spinal and nerve block, clear yellow synovial fluid, extensive scar tissue through the suprapatellar pouch and gutters and anteriorly.Additional 4mm bone cut on the distal femur due to flexion contracture, area on nonunion where tibia had collapsed medially this was excised as well as scar tissue, surgeon determined it would be more beneficial to the patient to go from primary knee to a semi constrained component to allow for better stability, good rom and stability.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: medical product: femur cemented, catalog # 42504606611, lot # 64463036.Unknown femoral stem extension 14x30, catalog # unknown, lot # unknown.Unknown tibial component, catalog # unknown, lot # unknown.Unknown tibial stem extension, catalog # unknown, lot # unknown.Unknown patella, catalog # unknown, lot # unknown.Biomet bc r 1x40 us, catalog # 110035368, lot # 915cak1905.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2023-00365, 0001822565-2023-00370, 0001822565-2023-00371, 0001822565-2023-00372 and 0001822565-2023-00373.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.According to cleveland clinic, steroids are often injected directly into joints to treat conditions such as rheumatoid arthritis, gout, or other inflammatory diseases.Steroids can also be injected into inflamed bursae (bursitis), or around inflamed tendons (tendinitis) near the shoulder, elbow, hip, knee, hand, or wrist.The indication for a steroid injection is related to inflammation and pain.The synovial membrane (synovium) encloses each joint and secretes fluid to allow joints to move freely.When the synovium is irritated by debris or pathogens, it over-secrets fluid causing local pain/tenderness, inflammation, swelling, and warmth, often resulting in mobility difficulties.Synovitis is treated with steroid injections to reduce the pain and inflammation or by arthroscopic or open synovectomy.As the complaint indicates, the patient required a steroid injection which resolved the pain and inflammation, and the implants remain intact without further complications.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ARTICULAR SURFACE FIXED BEARING CONSTRAINED CONDYLAR KNEE (CCK)
• 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: 16368399
• Report Number: 0001822565-2023-00366
• Device Sequence Number: 20718865
• Product Code: JWH
• UDI-Device Identifier: 00889024554313
• UDI-Public: (01)00889024554313(17)240331(10)64316885
• 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: 2020
• 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): 04/27/2023

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: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 42512800710
• Device Lot Number: 64316885
• 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: 01/20/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 138 KG
• Patient Race: White