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

Catalog Number	5531G209
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	07/11/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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".
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7928232
• Report Number: 0002249697-2018-03164
• Device Sequence Number: 1914513
• Product Code: JWH
• UDI-Device Identifier: 07613327045659
• UDI-Public: 07613327045659
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 5531G209
• Device Lot Number: LFN559
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 11/27/2018
• 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