MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO NRG X3 CR TIBIAL INSERT #11 10MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META

Catalog Number	82-6-1110
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other 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
As reported: "unstable total knee.Did poly swap".A scorpio nrg cr insert was revised.Update 24-january-2019: rep supplied an operative report with diagnosis "unstable left total knee arthroplasty, secondary to polyethylene wear".Procedure performed was "open debridement of the left knee with a poly liner exchange.".
Event or Problem Description
As reported: "unstable total knee.Did poly swap".A scorpio nrg cr insert was revised.Update 24-january-2019: rep supplied an operative report with diagnosis "unstable left total knee arthroplasty, secondary to polyethylene wear".Procedure performed was "open debridement of the left knee with a poly liner exchange.".
Additional Manufacturer Narrative
Correction: product history review: not performed as no lot information was provided.Previously reported lot code was incorrect.Lot code is unknown.Additional information: investigation conclusion: reported event: an event regarding instability involving a scorpio insert was reported.The event was not confirmed further to medical review.Method & results: product evaluation and results: no product was returned for evaluation.Clinician review: a review of the provided medical records by a clinical consultant indicated: on (b)(6) 2019, an open debridement and poly exchange of the left knee was performed for a diagnosis of ¿unstable left tka secondary to poly wear¿.There is no clinical or past medical history, no primary operative report, no x-rays available for review, and no examination of the explanted component.In this large, active male patient, some poly wear is not unexpected after over nine years in situ.Description of ¿mild amount wear centrally with no oxidation visible¿ is not consistent with a product with problematic manufacturing or material factors.Less than optimal soft tissue balancing or component positioning may have contributed to this clinical situation.Product history review: not performed as no lot information was provided.Previously reported lot code was incorrect.Lot code is unknown.Complaint history review: not performed as no lot information was provided.Conclusion: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.The medical review revealed: on (b)(6) 2019, an open debridement and poly exchange of the left knee was performed for a diagnosis of ¿unstable left tka secondary to poly wear¿.In this large, active male patient, some poly wear is not unexpected after over nine years in situ.Description of ¿mild amount wear centrally with no oxidation visible¿ is not consistent with a product with problematic manufacturing or material factors.Less than optimal soft tissue balancing or component positioning may have contributed to this clinical situation.Further information such as clinical or past medical history, primary operative report, x-rays and examination of the explanted component are required to complete the investigation for determining 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.

• Brand Name: SCORPIO NRG X3 CR TIBIAL INSERT #11 10MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8285276
• Report Number: 0002249697-2019-00356
• Device Sequence Number: 2463977
• Product Code: JWH
• UDI-Device Identifier: 07613327030785
• UDI-Public: 07613327030785
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K071991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• 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): 04/05/2019

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: 11/30/2021
• Device Catalogue Number: 82-6-1110
• Device Lot Number: 492PE6
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 04/05/2019
• 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: 73 YR
• Patient Weight: 127