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	82-3-0910
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/09/2019
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.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that patient underwent total knee arthroplasty 2 years ago.The patient complained of instability and visited to hospital.X-ray showed hyper extension of patient knee.Revision surgery was performed on (b)(6) 2019 and surgeon found scorpio nrg post of insert was broken.The broken insert was replaced and revision surgery was completed successfully.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a scorpio insert was reported.The event was confirmed through visual evaluation of the provided photograph.Method & results: device evaluation and results: no product was returned for evaluation however a photograph was provided.The photograph shows a recently explanted insert with its locking wire removed.The post is fractured on the insert.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: cannot confirm event, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.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 lot referenced.Conclusion: no product was returned for evaluation however a photograph was provided.The photograph shows a recently explanted insert with its locking wire removed.The post is fractured on the insert.The exact cause of the event cannot be confirmed as insufficient information was provided.Further information such as product return, primary and revision operative reports, clinical and past medical history, additional serial dated x-rays are required to complete the investigation and determine a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that patient underwent total knee arthroplasty 2 years ago.The patient complained of instability and visited to hospital.X-ray showed hyper extension of patient knee.Revision surgery was performed on (b)(6) 2019 and surgeon found scorpio nrg post of insert was broken.The broken insert was replaced and revision surgery was completed successfully.

• 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: 9131167
• Report Number: 0002249697-2019-03340
• Device Sequence Number: 2377417
• Product Code: JWH
• UDI-Device Identifier: 04546540364494
• UDI-Public: 04546540364494
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K030978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 82-3-0910
• Device Lot Number: 51519501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 11/22/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 78 YR