MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIA TRABECULAR METAL TWO-PEG POROUS FXD BEARING LT SIZE D; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient was revised for tibial subsidence approximately 4 months post implantation.No additional information is available at this time.
Additional Manufacturer Narrative
(b)(4).G2: australia.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products.Unk size 8 uncemented femur size d.Unk- 10mm poly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d1, d2, d3, d4, g1, g3, g4, g6, h1, h2, h3, h4, h6, h10 the investigation remains in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient was revised for tibial subsidence and pain approximately 4 months post implantation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.  visual examination of the provided pictures identified sign of use.Back of tibial plate had tissue covered and pegs were cut off.No product was returned to perform additional evaluation.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: initial op note found no intra-operative complications.No other notes were provided.X-ray review noted left tka with significant radiolucency at the bone cement interface and lateral component subsidence indicating loosening.No fracture.Complaint was confirmed based on provided medical record.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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: TIBIA TRABECULAR METAL TWO-PEG POROUS FXD BEARING LT SIZE D
• 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: 18093455
• Report Number: 0001822565-2023-03121
• Device Sequence Number: 12325807
• Product Code: JWH
• UDI-Device Identifier: 00889024510531
• UDI-Public: (01)00889024510531(17)320830(10)65574980
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42530006701
• Device Lot Number: 65574980
• 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: 10/17/2023
• Supplement Date Received by Manufacturer: 11/08/2023; 03/04/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 11/30/2023; 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 75 KG