MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO TS TIB INSERT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	72-4-0316
Medical Device Problem Codes	Detachment Of Device Component (1104); Fitting Problem (2183)
Health Effect - Clinical Codes	Fall (1848); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
Event or Problem Description
Metal locking rim on poly did not engage and fell upon impaction.The surgeon described the poly as 'falling in' instead of clipping and locking in.Unable to use liner and was unable to complete a liner change during this stage of a washout.The patient was coming back to theatre for another washout in 3 days time.The surgeon will complete the change then.
Additional Manufacturer Narrative
Reported event: an event regarding a seating/locking issue involving a scorpio insert was reported.The event was not confirmed.Method and results: -device evaluation and results: not performed as the device was not returned.-medical records received and evaluation: not performed as no medical records were provided.-device history review: the device was 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.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of device, operative reports x-rays, patient history and follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.
Event or Problem Description
Metal locking rim on poly did not engage and fell upon impaction.The surgeon described the poly as 'falling in' instead of clipping and locking in.Unable to use liner and was unable to complete a liner change during this stage of a washout.The patient was coming back to theatre for another washout in 3 days time.The surgeon will complete the change then.

• Brand Name: SCORPIO TS TIB INSERT
• 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: 6487708
• Report Number: 0002249697-2017-01234
• Device Sequence Number: 16476639
• Product Code: JWH
• UDI-Device Identifier: 07613327034325
• UDI-Public: (01)07613327034325(11)160712(17)210731(11)56331201
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K994128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 72-4-0316
• Device Lot Number: 56331201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2017
• Supplement Report FDA Received Date: 06/15/2017
• 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: Other
• Patient Age: 68 YR