MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE WITH HINGE POST EXTENSION SCREW; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	02/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) year of birth: (b)(6).Concomitant medical devices: 00588001401 63614821 femoral component; unknown tibial tray.Foreign country: (b)(6).Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified both hinge post and post extension was fracture, and threads were stripped.The device was submitted for further analysis.The analysis determined of both fractured hinge post and extension post was due to fatigue mode fracture.The fracture surface of the extension post showed severe post-fracture damage, multiple fatigues crack initiation sites identified near the outer diameter edge of the fracture.The hinge post-fracture surface showed post-fracture damage and biological debris, multiple fatigues crack initiation sites identified near the inner diameter of the hinge.The material analysis was conforming to the print specification.Radiographs were provided and reviewed by a health care professional.Review of the available records identified fracture of the hinge portion of the left knee arthroplasty implants.Joint effusion and soft tissue swelling.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Per package insert, nexgen rotating hinge knee: pain, swelling, fracture are known adverse effect of the system.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
It was reported patient underwent total knee arthroplasty.Subsequently the patient was revised approximately two weeks post implantation due to pain and swollen knee.During surgery implant fracture was discovered.Post implantation patient is in general condition and irritation free, but still slightly swollen wound conditions from acute inpatient treatment first released into their home environment.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: ARTICULAR SURFACE WITH HINGE POST EXTENSION SCREW
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10378484
• Report Number: 0001822565-2020-02847
• Device Sequence Number: 3168454
• Product Code: JWH
• UDI-Device Identifier: 00889024199309
• UDI-Public: (01)00889024199309
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2020

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: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 00588004012
• Device Lot Number: 64142752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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