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

Catalog Number	82-3-0512
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.
Event or Problem Description
It was reported by the sales representative that when the surgeon impacted the insert into tibial tray, it supposed to sit in flush and won't be able to lift because it is locked.Surgeon able to lift it up using dissector with the new replacement unit.No issues were mentioned regarding the baseplate.The 4th insert was implanted successfully.
Additional Manufacturer Narrative
An event regarding an assembly issue involving a scorpio insert trial was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection: visual inspection was performed as part of the material evaluation and indicated the following comments: ma: damage observed on insert consistent with explantation process.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Dimensional & functional inspection: the device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Material analysis material evaluation was completed and indicated the following comments: ma: damage observed on insert consistent with explantation process.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: 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 are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.
Event or Problem Description
It was reported by the sales representative that when the surgeon impacted the insert into tibial tray, it supposed to sit in flush and won't be able to lift because it is locked.Surgeon able to lift it up using dissector with the new replacement unit.No issues were mentioned regarding the baseplate.The 4th insert was implanted successfully.

• Brand Name: NRG KNEE P/S NRG BEARING INSERT SIZE
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8403632
• Report Number: 0002249697-2019-01273
• Device Sequence Number: 1811121
• Product Code: JWH
• UDI-Device Identifier: 04546540364364
• UDI-Public: 04546540364364
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K030978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2019

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: 03/31/2023
• Device Catalogue Number: 82-3-0512
• Device Lot Number: 64163301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 05/02/2019
• 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