MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO NRG X3 PS TIBIAL INSERT #5 12MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META

Catalog Number	82-7-0512
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Damage to Ligament(s) (1952); Injury (2348)
Date of Event	01/04/2019
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
On (b)(6) 2013 tka procedure done.The products #81-4406r, #or-7115-0005, #82-7-0512,#73-20-3508 were implanted in patient.On (b)(6) 2019, performing tka re-replacement surgery with mcl (medial collateral ligament) failure.The replacement implant is competitor 360.Implanted peg was broken and the 73-20-3508 x3 patella universal dome was broken also.
Event or Problem Description
On (b)(6) 2013 tka procedure done.The products #81-4406r, #or-7115-0005, #82-7-0512,#73-20-3508 were implanted in patient.(b)(6) 2019, performing tka re-replacement surgery with mcl (medial collateral ligament) failure.The replacement implant is competitor 360.Implanted peg was broken and the 73-20-3508 x3 patella universal dome was broken also.
Additional Manufacturer Narrative
An event regarding revision due to mcl (medial collateral ligament) failure involving a scorpio insert was reported.Conclusion: based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event.A material analysis report (mar) of the returned device confirmed that the damage present on the articulating surface of the tibial insert was consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.As reported the revision surgery was taken place due to mcl (medial collateral ligament) failure and x3 patella fracture.The whole construct were revised to zan vanguard 360 (non-stryker components).A full investigation is completed on the scorpio patella (pr 1979172) under the same pi.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 PS TIBIAL INSERT #5 12MM
• 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: 8285950
• Report Number: 0002249697-2019-00364
• Device Sequence Number: 11297904
• Product Code: JWH
• UDI-Device Identifier: 07613327030983
• UDI-Public: 07613327030983
• Combination Product (Y/N): N
• PMA/510(K) Number: K071991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 06/12/2019

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 Catalogue Number: 82-7-0512
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 06/12/2019
• 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 Weight: 88