MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN CRUCIATE RETAINING PROLONG ARTICULAR SURFACE SIZE GREEN/C-H 12MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty revision of the articular surface to address pain and instability secondary to polyethylene wear approximately six (6) years post-operatively.During the procedure, the femoral and tibial tray components were found to be stable and remained implanted.Attempts have been made; however, no additional information is available.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - nexgen tibial tray size 5 catalog #: 00595404701 lot #: 63228360, nexgen femoral component catalog #: 6559521505 lot #: 61654422.G2 - report source - foreign: event occurred in australia.The complainant has indicated that the product will not be returned to zimmer biomet for investigation due to hospital policy.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : investigation incomplete.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The reported event was able to be confirmed by review of the provided medical records and provided photos of explanted device.Visual examination of the provided photos identified the device is fractured and worn; as no product was returned, visual and dimensional evaluations could not be performed.Provided radiographs were reviewed by a healthcare professional and identified medial compartment narrowing; no acute fracture and no radiolucency identified.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause could not be determined.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 additional information to report.

• Brand Name: NEXGEN CRUCIATE RETAINING PROLONG ARTICULAR SURFACE SIZE GREEN/C-H 12MM
• 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: 18940841
• Report Number: 0001822565-2024-00931
• Device Sequence Number: 15580895
• Product Code: JWH
• UDI-Device Identifier: 00889024208025
• UDI-Public: (01)00889024208025(17)210131(10)63264558
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K013991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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 Expiration Date: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00595204012
• Device Lot Number: 63264558
• 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: 02/23/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2016
• 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: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 91 KG