MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #2 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 5531G209

Device Problem Material Discolored (1170)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 07/11/2018

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no relevant reported discrepancies.There has been one more event 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.The following devices were also listed in this report: triathlon prim cem fxd bplt, cat#5520b200 ; lot#b0cp4p.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

Hospital practitioner reported the following event : " previously pre-coated of a tibial implant of ptg.Elimination of an infection, presence of a change in appearance of the polyethylene tibial plateau that is yellow".

Manufacturer Narrative

Added update in the event description.An event regarding infection involving a triathalon insert was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as product was not returned -medical records received and evaluation: no medical records were received for review with a clinical consultant -device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot or sterile lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes, pathology reports,x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

Hospital practitioner reported the following event : " previously pre-coated of a tibial implant of ptg.Elimination of an infection, presence of a change in appearance of the polyethylene tibial plateau that is yellow" information received from the ansm : d"ate of occurrence: (b)(6) 2018 description of the incident: early loosening < 1 year of a ptg tibial implant.Elimination of an infection.Presence of a change in the appearance of the polyethylene tibial plateau which is yellow.

• Brand Name: X3 TRIATHLON CS INSERT #2 9MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7928232
• MDR Text Key: 122446573
• Report Number: 0002249697-2018-03164
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07613327045659
• UDI-Public: 07613327045659
• 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: 11/27/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 5531G209
• Device Lot Number: LFN559
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/06/2018
• Initial Date FDA Received: 10/02/2018
• Supplement Dates Manufacturer Received: 10/31/2018
• Supplement Dates FDA Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention