MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5521-B-500
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Size #5 baseplate and augment didn't sit flush together.When augment used with a replacement baseplate (#5), augment and baseplate sat properly.
Additional Manufacturer Narrative
An event regarding seating/locking issues involving a triathlon baseplate was reported.The event was not confirmed.Conclusions: the reported event is not confirmed.The returned device was found to be within specifications dimensionally and functionally.See attached inspection report.Discussion with marketing and product support engineering group assessed both devices and found the devices to be functionally acceptable.If additional information becomes available, this investigation will be reopened.
Event or Problem Description
Size #5 baseplate and augment didn't sit flush together.When augment used with a replacement baseplate (#5), augment and baseplate sat properly.

• Brand Name: TRI TS BASEPLATE SIZE 5
• 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: 7446861
• Report Number: 0002249697-2018-01186
• Device Sequence Number: 19323580
• Product Code: MBH
• UDI-Device Identifier: 07613327026320
• UDI-Public: 07613327026320
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 08/20/2018

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: 02/28/2023
• Device Catalogue Number: 5521-B-500
• Device Lot Number: BE79YA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 08/20/2018
• 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
• Patient Age: 59 YR
• Patient Weight: 81