MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO U-DOME X3 PATELLA; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY

Catalog Number	73-20-3508
Medical Device Problem Code	Break (1069)
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.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.
Additional Manufacturer Narrative
An event regarding crack/fracture and revision due to mcl (medial collateral ligament) failure involving a scorpio patella was reported.The event of crack/fracture was confirmed based on the mar of the returned device.The event of revision due to mcl failure is not confirmed.Method & results: device evaluation and results: the returned devices were examined with the aid of a stereomicroscope at magnifications up to 200x.This inspection indicated the fracture morphology of the patella insert was consistent with overload.The damage present on the articulating surface of the patella insert was consistent with scratching and third body indentations; which are common damage modes of uhmwpe.Dimensional and functional inspection were not performed as the device were returned damaged.Material analysis is not completed as the event is not related to the material integrity.Medical records received and evaluation: the provided medical records were deemed insufficient by a clinical consultant indicated: provided image showed fractured patella.Need operative reports, clinical/office notes, histopathology reports, serial x-rays and examination of the explanted components.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the investigation concluded that crack/facture of the patella was caused by overload.This inspection indicated the fracture morphology of the patella insert was consistent with overload.The damage present on the articulating surface of the patella insert was consistent with scratching and third body indentations; which are common damage modes of uhmwpe.The root cause of the mcl failure could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SCORPIO U-DOME X3 PATELLA
• Common Device Name: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8285946
• Report Number: 0002249697-2019-00365
• Device Sequence Number: 1259334
• Product Code: NPJ
• UDI-Device Identifier: 07613327014570
• UDI-Public: 07613327014570
• Combination Product (Y/N): N
• PMA/510(K) Number: K052917
• 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: 73-20-3508
• 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