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

Catalog Number	82-3-0508
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that the surgeon found some scratches on n2vac after tka final implantation during tka operation.Then he removed the insert right away and replace it to another.
Additional Manufacturer Narrative
An event regarding damage of a scorpio nrg insert was reported.The event was not confirmed.Device evaluation and results: a visual inspection was performed by a mar engineer which observed minor scratches on the articulating surface and explantation damage.Dimensional inspection: not performed as reported event is not a dimensional issue.Functional inspection: not performed as reported event is not related to function of device.Medical records received and evaluation: not performed as no medical records were provided.Device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.A review of the dhr confirmed that all parts passed all visual inspection steps.Complaint history review: there have been no other events for this lot.The exact cause of the event could not be confirmed.If further relevant information becomes available this investigation will be re-opened.
Event or Problem Description
It was reported that the surgeon found some scratches on (b)(4) after tka final implantation during tka operation.Then he removed the insert right away and replace it to another.

• 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: 6354955
• Report Number: 0002249697-2017-00649
• Device Sequence Number: 16152889
• Product Code: JWH
• UDI-Device Identifier: 04546540364340
• UDI-Public: (01)04546540364340(11)160824(17)210831(10)56846501
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K030978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 82-3-0508
• Device Lot Number: 56846501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/25/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2017
• Supplement Report FDA Received Date: 04/28/2017
• 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: Other