MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN SCORPIO NRG BASEPLATE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number UNK_JR

Device Problems Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 09/07/2023

Event Type  Injury  

Manufacturer Narrative

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.The following devices were also listed in this report: device name#scorpio nrg femur ; cat#unknown ; lot#unknown.Device name#scorpio nrg baseplate ; cat#unknown ; lot#unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : device remains implanted.

Event Description

Patient had left primary tkr done 14 years ago using stryker nrg implant, now complaining of pain.

Manufacturer Narrative

Reported event: an event regarding loosening involving an unknown scorpio baseplate was reported.The event was confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a review of the provided medical records by a clinical consultant indicated: "the x-rays demonstrate a scorpio nrg knee implanted on the left side.On the ap the tibial component is noted to be in several degrees of varus with slight lucency underneath the lateral aspect of the component.No gross mechanical failure is evident.The postoperative x-rays show a cemented stemmed ts revision tka in anatomic position.No information regarding causation for the need for revision was provided.It is confirmed a revision tka was performed.The root cause and indications for this revision tka cannot be determined from the information provided.Should additional information become available i would be happy to further this assessment." -product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to pain.A review of the provided medical records by a clinical consultant indicated: "the x-rays demonstrate a scorpio nrg knee implanted on the left side.On the ap the tibial component is noted to be in several degrees of varus with slight lucency underneath the lateral aspect of the component.No gross mechanical failure is evident.The postoperative x-rays show a cemented stemmed ts revision tka in anatomic position.No information regarding causation for the need for revision was provided.It is confirmed a revision tka was performed.The root cause and indications for this revision tka cannot be determined from the information provided.Further information such as return of the device and device information, pathology reports, revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.The following devices were also listed in this report: device name#scorpio nrg femur ; cat#unknown; lot#unknown.Device name#scorpio nrg insert; cat#unknown; lot#unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

Patient had left primary tkr done 14 years ago using stryker nrg implant, now complaining of pain.Update as per med review: on the ap the tibial component is noted to be in several degrees of varus with slight lucency underneath the lateral aspect of the component.No gross mechanical failure is evident.The postoperative x-rays show a cemented stemmed ts revision tka in anatomic position.

• Brand Name: UNKNOWN SCORPIO NRG BASEPLATE
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17836532
• MDR Text Key: 324508357
• Report Number: 0002249697-2023-01096
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian