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

Device Problem Mechanical Problem (1384)

Patient Problems Pain (1994); Injury (2348)

Event Date 07/19/2018

Event Type  Injury  

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 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".

Event Description

As reported: "this subject is a participant in the triathlon ts outcomes 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".

Manufacturer Narrative

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 review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Review indicated there have been no other similar events for the reported lot.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.

• Brand Name: TRI POST AUGMENT SZ5 5MM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7823225
• MDR Text Key: 118449541
• Report Number: 0002249697-2018-02694
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327014853
• UDI-Public: 07613327014853
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 5543-A-500
• Device Lot Number: IMJH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 84