MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET CC CRUCIATE TRAY 63MM; PROSTHESIS, KNEE

Catalog Number	141231
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	10/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a clinical study that a patient underwent an initial right total knee arthroplasty.Subsequently, approximately seven (7) weeks post-implantation, the patient was hospitalized due to pain in the implanted joint.An additional pain medication was prescribed and the pain was resolved one (1) week later.Due diligence is in progress for this event; to date no additional information has been made available.
Additional Manufacturer Narrative
(b)(4).D10: medical product: vanguard cr ilok fem-rt 60: catalog#183004, lot#j6935475; vngd cr tib brg 10x63/67: catalog#183420, lot#462590.G2: foreign: germany.The product will not be returned to zimmer biomet for investigation, as the product currently remains implanted.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported via a clinical study that a patient underwent an initial right total knee arthroplasty.Subsequently, approximately seven (7) weeks post-implantation, the patient was hospitalized due to pain in the implanted joint.During the stay, all diagnostic findings were negative.An additional pain medication was prescribed and the patient was instructed to rest until symptoms improved.The pain was resolved one (1) week later.All available information has been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h6; h11.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: moderate swelling (no effusion), pain medially with x-rays taken unchanged when compared to the post-operative imaging.There were no signs of loosening, no material fracture, no evidence of periprosthetic fracture.Suprapatellar joint effusion with central position of the patella.There was no evidence of infection, pain medication was adjusted, wound intact without any complications.Root cause was unable to be determined.Reported event was confirmed by review of provided medical records.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 at time of this report.

• Brand Name: BIOMET CC CRUCIATE TRAY 63MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20878866
• Report Number: 0001825034-2024-02891
• Device Sequence Number: 7683648
• Product Code: JWH
• UDI-Device Identifier: 00880304231917
• UDI-Public: (01)00880304231917(17)300518(10)J6791464
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K171054
• 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: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2025

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 Catalogue Number: 141231
• Device Lot Number: J6791464
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: 01/08/2025; 04/08/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 01/23/2025; 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2020
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female