MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ROTATING HINGE KNEE ARTICULAR SURFACE WITH HINGE POST EXTENSION SIZE B; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: nexgen rotating hinge knee option femoral component size b right, catalog #: 00588001202, lot #: 62958315.Nexgen rotating hinge knee modular tibial component, catalog #: 00588000102, lot #: 64100323.Nexgen stem extension 11mm x 145mm, catalog #: 00598801011, lot #: 64223627.Nexgen all poly patella 26mm, catalog #: 00597206526, lot #: 63518713.Report source - foreign: (b)(6).The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It is reported that the patient underwent a closed reduction of the right knee to address displacement of the hinge less than four (4) months following knee arthroplasty.The patient is doing well post-operatively and no additional consequences were reported.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g4, g7, h2, h3, h6, h10.The product was evaluated through manufacturing review, however, the reported event could not be confirmed.Radiographs provided indicated a change in contour of the hinge post, potentially indicating fracture, however, this could not be confirmed.The device history records were reviewed and no discrepancies were identified.Per the package insert, pain and dislocation are known potential adverse effects of the procedure.A definitive root cause could not be determined with the information provided.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.

• Brand Name: NEXGEN ROTATING HINGE KNEE ARTICULAR SURFACE WITH HINGE POST EXTENSION SIZE B
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9136168
• Report Number: 0001822565-2019-04233
• Device Sequence Number: 19594687
• Product Code: JWH
• UDI-Device Identifier: 00889024199187
• UDI-Public: (01)00889024199187
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2020

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: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00588002012
• Device Lot Number: 63988111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 05/05/2020
• 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