MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ROTATING HINGE KNEE PRECOAT NONMODULAR TIBIAL COMPONENT SIZE 2; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	04/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant devices - nexgen rotating hinge knee articular surface with hinge post extension size c 20mm catalog #: 00588003020 lot #: 63843248, nexgen option cemented femoral component size c left catalog #: 00588001301 lot #: 63745902, nexgen rotating hinge knee femoral hinge service kit size c catalog #: 00588009013 lot #: 63630825, nexgen straight stem extension 12mm x 100mm catalog #: 00598801012 lot #: 63959224 report source - foreign: (b)(6).The complainant has not yet indicated whether the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty revision approximately 30 months post-operatively to address tibial component loosening.Attempts have been made, however, no additional information is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b6, g3, g6, h2, h3, h6, h10.The complaint sample was evaluated through photographic inspection and the reported event confirmed through review of medical records.Visual examination of provided pictures of the tibial component showed signs of use and the tibial stem had partial bone cemented adhered to it.The device history records were reviewed and no discrepancies were identified.Per the package insert, loosening is a known adverse effect of the knee system.However, 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NEXGEN ROTATING HINGE KNEE PRECOAT NONMODULAR TIBIAL COMPONENT SIZE 2
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11739851
• Report Number: 0001822565-2021-01177
• Device Sequence Number: 17198542
• Product Code: JWH
• UDI-Device Identifier: 00889024198975
• UDI-Public: (01)00889024198975(17)220731(10)11022037
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2021

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: 07/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00588000202
• Device Lot Number: 11022037
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 05/17/2021
• 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