MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN STEMMED PRECOAT TIBIAL COMPONENT SIZE 3; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products- nexgen lps-flex articular surface size e f 10mm catalog #: 00596403210 lot #: 63142340, nexgen gender solutions lps-flex porous femoral component size e right catalog #: 00576201552 lot #: 11015728, nexgen all poly patella size 32mm catalog #: 00597206532 lot #: 63283204.Report source: (b)(6).The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Investigation incomplete.
Event or Problem Description
It is reported that the patient underwent a knee arthroplasty revision to address pain and tibial component migration.No additional patient consequences were identified.Attempts have been made and no further information is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
The product was evaluated through photographic inspection and manufacturing review.Photographic review of the device showed surface wear on the polyethylene articular surface and surface scratches on the tibial tray.The device history records were reviewed and identified one (1) piece scrapped for unknown reasons that may be related to the event.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.

• Brand Name: NEXGEN STEMMED PRECOAT TIBIAL COMPONENT SIZE 3
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 9199337
• Report Number: 0002648920-2019-00750
• Device Sequence Number: 13565304
• Product Code: JWH
• UDI-Device Identifier: 00889024217577
• UDI-Public: (01)00889024217577
• 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: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2019

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: 09/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 00598003701
• Device Lot Number: 63472892
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 11/06/2019
• 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