MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #7 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5531G711

Device Problems Scratched Material (3020); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091); Injury (2348)

Event Date 01/30/2018

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 events for the lot referenced.There have been no other events for the sterile lot referenced.A supplemental report will be submitted upon completion of the investigation.The following devices were also listed in this report: triathlon cr fem comp #6 l-cem; 5510f601; b933s; triathlon prim cem fxd bplt #7; 5520b700; b3d7y; triathlon asymmetric x3 patella; 5551-g-401; np3w.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

Patient had a primary total knee on (b)(6) 2017 and it became infected and surgeon removed the primary insert, washed out the joint, and put in a new insert.

Manufacturer Narrative

An event regarding infection involving a triathlon insert was reported.The event was not confirmed.One insert was returned for evaluation.Burnishing, scratching and third body indentations were observed on the insert.Damage consistent with the explantation process were also observed on the insert.Medical records received and evaluation: not performed as no medical records were provided for review.Indicate all devices were manufactured and accepted into final stock on with no reported discrepancies.There have been no other events for the lot or sterile lot referenced.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pre- and post-operative x-rays, operative reports, pathology reports including the strain of infection identified, as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this investigation will be reopened.

Event Description

Patient had a primary total knee on (b)(6) 2017 and it became infected and surgeon removed the primary insert, washed out the joint, and put in a new insert.

• Brand Name: X3 TRIATHLON CS INSERT #7 11MM
• 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: 7299585
• MDR Text Key: 101056485
• Report Number: 0002249697-2018-00559
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327046038
• UDI-Public: 07613327046038
• 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: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 5531G711
• Device Lot Number: LFY721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Date Manufacturer Received: 03/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR