MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 6; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5521-B-600
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2018
Type of Reportable Event	Malfunction
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 similar events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Primary knee, rep was not present for the procedure.It was reported that the surgeon did not like how the 'nub' engaged with the baseplate threads.Surgeon elected not to implant the device.Another device (same catalog, different lot) was opened and performed as expected.Surgery completed successfully.No delay was reported.
Event or Problem Description
Primary knee, rep was not present for the procedure.It was reported that the surgeon did not like how the 'nub' engaged with the baseplate threads.Surgeon elected not to implant the device.Another device (same catalog, different lot) was opened and performed as expected.Surgery completed successfully.No delay was reported.
Additional Manufacturer Narrative
Reported event: an event regarding an alleged seating/locking issue involving a triathlon baseplate was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual inspection showed no signs of use or abuse, nor any signs of any abnormalities.A functional inspection was performed where the end cap and baseplate were assembled by a trained operator.The torque wrench gage reading was within the requirement and the assembled components were deemed acceptable.-medical records received and evaluation: not performed as medical records were not received for review with a clinical consultant.-device history review: the reported device was manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there has been no other similar events reported for this manufacturing lot.Conclusions: the returned baseplate was functionally inspected to be within specification and functionally tested to perform satisfactorily.There is no indication the event is related to a manufacturing issue.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

• Brand Name: TRI TS BASEPLATE SIZE 6
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8202440
• Report Number: 0002249697-2018-04151
• Device Sequence Number: 19246811
• Product Code: MBH
• UDI-Device Identifier: 07613327026337
• UDI-Public: 07613327026337
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• 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): 03/12/2019

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: 10/31/2023
• Device Catalogue Number: 5521-B-600
• Device Lot Number: B9T7BA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 03/12/2019
• 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: Other
• Patient Age: 70 YR
• Patient Weight: 105