MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE EF 10 MM HEIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Loss of Range of Motion (2032)
Date of Event	07/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent a knee arthroplasty.Subsequently, patient was revised approximately 2 years, 6 months post procedure for locking of the knee.It was noted in the revision that the post on lps poly had fractured and was replaced.
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 Manufacturer Narrative
This follow-up report is being submitted to relay additional information.  visual examination of the returned product identified signs of wear (nicks, gouges) , the dovetail feature is flared, and the post feature fractured.The device was submitted for further analysis.Analysis determined the superior side of the bearing shows evidence of possible impingment damage at the anterior side of the fracture surface, there is also possible evidence of impingment damage on the anterior side of the post fragment, the fracture surfaces of the post fragment and main body of the bearing fit together generally well but not precisely, and possibly indicating that there was additional plastic deformation of the fragment and wear on both pieces occurring after the separation, conclusion: the post fracture was possibly caused by overloading exacerbated by impingment damage to the posterior side of the post.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Insufficient information provided to perform a compatibility check.Medical records were not provided.Complaint is confirmed with product return.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: ARTICULAR SURFACE SIZE EF 10 MM HEIGHT
• 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: 17491978
• Report Number: 0001822565-2023-02120
• Device Sequence Number: 7246685
• Product Code: JWH
• UDI-Device Identifier: 00889024211483
• UDI-Public: (01)00889024211483(17)221031(10)63826343
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 12/05/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00596205110
• Device Lot Number: 63826343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/21/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2017
• 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: Male
• Patient Weight: 126 KG