MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET CC CRUCIATE TRAY 67MM; PROSTHESIS, KNEE

Catalog Number	141232
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544); Ankylosis (4527); Swelling/ Edema (4577); Arthrofibrosis (4885)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial right total knee arthroplasty.Following the procedure, the patient continued having pain and neuropathy in the leg with limited range of motion.Diagnostics revealed damage to the peroneal nerve resulting in foot drop and difficulty ambulating.Physical exam revealed a palpable baker¿s cyst, and x-rays showed excessive tibial slope.Subsequently, approximately four (4) months post-implantation, a manipulation under anesthesia was performed due to ankylosis and arthrofibrosis.All available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: medical product: vanguard cr por fem-rt 65: catalog#183048, lot#900670; series a pat w/wr std 28 1 peg: catalog#184702, lot#65783328; vgd ve as tib brg 67x10mm: catalog#ve189040, lot#65268828.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; h2; h3; h4; h6; h10; 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.Office visit post initial surgery provided states that patient was experiencing right knee pain (achy/burning with numbness, tingling), swelling, difficulty ambulating and the knee was never fully extended.A baker's cyst was identified post-surgery.The patient tried to stand up on the beach but felt severe pain with loud noise from the knee.Subsequently the patient feels pain with prolonged walking, experienced significant swelling post-surgery, which extended into her abdomen and hip.Patient also developed a right foot drop, attributed to nerve damage, and also had right peroneal neuropathy which is located at the level of the knee with deep injury to the deep peroneal nerve.Patient also reports a lack of motion in the foot, which prevents standing up.X-rays show knee with excessive tibial slope.Patient underwent manipulation under anesthesia due to foot drop from peroneal nerve palsy and arthrofibrosis.Reported event was confirmed by review of provided medical records.Regarding the pain, limited range of motion, swelling, nerve damage, and noise, a definitive root cause cannot be determined.Regarding the baker's cyst, investigation results concluded that the root cause of the reported event is unrelated to the device.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 67MM
• 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: 23537688
• Report Number: 0001825034-2025-03592
• Device Sequence Number: 9083592
• Product Code: JWH
• UDI-Device Identifier: 00887868558665
• UDI-Public: (01)00887868558665(17)330504(10)J7510816
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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: Lay User/Patient
• Device Catalogue Number: 141232
• Device Lot Number: J7510816
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2023
• 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
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native, White