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

Catalog Number	00596202210
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial right total knee arthroplasty.Subsequently, five (5) years and six (6) months post-implantation, the post of the articular surface fractured.A revision surgery was performed to replace the affected bearing without reported complication.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).D10: medical product: unknown femoral component: catalog#ni, lot#ni; unknown tibial tray: catalog#ni, lot#ni the product has been received by zimmer biomet and the investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
Visual examination of the returned product/provided pictures found the product to exhibit signs of use/wear (pits, discoloration, micromotion) and confirmed the post feature fractured.Unable to verify product identifiers or size due to wear.Device was submitted for further analysis.Analysis determined: the post of the bearing is separated from the main body of the bearing.The post fragment was also returned for examination.The superior surface of the bearing shows evidence of possible linear scratches and some minor pitting, gouging, or abrasions, all of which are typical with in-vivo use.The inferior side shows pitting and abrasions also typical with in-vivo use, plus some possible cold flow of the uhmwpe into the through holes of the tibial plate.The fracture surface on the bearing shows possible impingement damage on the anterior side; there is similar possible impingement damage on the right-hand anterior side of the base of the post fragment.The posterior side of the post fragment also shows possible impingement damage separate from the fracture surface.Conclusion: the post fracture was caused by overloading, possibly exacerbated by impingement from the femoral component, possibly on both anterior and posterior sides of the post.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.Complaint sample was evaluated and the reported event was confirmed.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: NEXGEN ARTICULAR SURFACE SIZE CD 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: 19567270
• Report Number: 0001822565-2024-02064
• Device Sequence Number: 6305867
• Product Code: JWH
• UDI-Device Identifier: 00889024210905
• UDI-Public: (01)00889024210905(17)230731(10)64093515
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

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: 07/31/2023
• Device Catalogue Number: 00596202210
• Device Lot Number: 64093515
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/03/2024
• 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: 05/29/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2018
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 77 KG