MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI POST AUGMENT SZ5 5MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5543-A-500
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	07/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device 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.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
As reported: "this subject is a participant in the (b)(6) study.An adverse event form was received on (b)(6) 2018 noting that this subject had a revision of the femoral component on (b)(6) 2016 due to progressive loosening of the femoral component.No other previous adverse event forms had been submitted.The 2-year follow-up visit on (b)(6) 2016 noted that the subject was experiencing moderate pain".
Additional Manufacturer Narrative
An event regarding loosening involving a triathlon augment was reported.The event was confirmed.Method & results: device evaluation and results: not performed as the reported device was not returned for evaluation.Medical records received and evaluation: a medical review noted; review of these records confirms revision tka for femoral component loosening occurred, however, the root cause cannot be determined as insufficient information was available.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusion: a medical review concluded loosening however the root cause could not be determined.Further information such as additional imaging and laboratory reports related to the two revision surgeries & implant retrieval with material analysis are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.
Event or Problem Description
As reported: "this subject is a participant in the triathlon ts outcomes study.An adverse event form was received on july 31, 2018 noting that this subject had a revision of the femoral component on (b)(6) 2016 due to progressive loosening of the femoral component.No other previous adverse event forms had been submitted.The 2-year follow-up visit on (b)(6) 2016 noted that the subject was experiencing moderate pain".

• Brand Name: TRI POST AUGMENT SZ5 5MM
• 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: 7823055
• Report Number: 0002249697-2018-02689
• Device Sequence Number: 1116921
• Product Code: MBH
• UDI-Device Identifier: 07613327014853
• UDI-Public: 07613327014853
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2018

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 Expiration Date: 04/30/2019
• Device Catalogue Number: 5543-A-500
• Device Lot Number: JZNH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 11/20/2018
• 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; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 84