MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NRG KNEE P/S NRG BEARING INSERT SIZE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	82-3-0515
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Patient diagnosed with broken post of nrg tibial insert.
Additional Manufacturer Narrative
An event regarding crack/fracture involving scorpio trial was reported.The event was confirmed following completion of a material analysis report.Method & results: -device evaluation and results: visual inspection: visual inspection was performed as part of the material analysis report (mar), dated 10 jan 2020.This inspection indicated.Visual analysis: the returned device was examined with the aid of a stereomicroscope at magnifications up to 50x.Nothing noteworthy was observed onthe explanted locking wire.Damage was observed on the distal and anterior surfaces of the insert which is consistent with the explantation process.Backside impressions on the distal surface of insert are consistent with contact against a tibial base plate.Damage was observed on the articulating surface of the insert which is consistent with contact against the femoral component.The damage present on the articulating surface is consistent with burnishing, scratching, and third body indentations; these are common damage modes of uhmwpe.Macroscopic surface features indicate that the post failed in fatigue with the fracture initiating posteriorly and propagating posteriorly.The other side of the fracture surface is shown which also has macroscopic surface features indicating a fatigue fracture propagating posteriorly.Dimensional inspection: not performed as the reported device was implanted and subsequently explanted.The device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Functional inspection: not performed as the reported device was implanted and subsequently explanted.The device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Material analysis a material analysis has been performed.The report concluded: conclusion: the post of the insert fractured in fatigue, the fracture initiated on the anterior surface and propagated posteriorly.The fracture mode is consistent with repeated contact against the femoral component.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.T based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-clinician review: no medical records were received for review with a clinical consultant.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays are needed to fully investigate the event.If further information becomes available this investigation will be re-opened.
Event or Problem Description
Patient diagnosed with broken post of nrg tibial insert.

• Brand Name: NRG KNEE P/S NRG BEARING INSERT SIZE
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9495514
• Report Number: 0002249697-2019-04069
• Device Sequence Number: 16447878
• Product Code: JWH
• UDI-Device Identifier: 04546540364371
• UDI-Public: 04546540364371
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K030978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 82-3-0515
• Device Catalogue Number: 82-3-0515
• Device Lot Number: 58934301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Received by Manufacturer: 11/23/2019
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention