MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #2 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	5531G211
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	06/25/2018
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 events for the lot referenced.It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.The following devices were also listed in this report: triathlon cr fem comp #3 l-cem; cat# 5510f301; lot# b9c6l.Triathlon prim cem fxd bplt #2; cat# 5520b200; lot# c9r7n.Triathlon asymmetric x3 patella; cat# 5551-g-320; lot# 1dtv.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It was reported that patient's left knee was revised.As reported by rep: "patient presented with possible sinus tract [a narrow channel in the body that allows the release of fluid] in incision of previous surgery.Patient was washed out and the liner was exchanged.A size 2 11mm cs insert was removed and swapped out for a new one".

• Brand Name: X3 TRIATHLON CS INSERT #2 11MM
• 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: 7711211
• Report Number: 0002249697-2018-02267
• Device Sequence Number: 13665034
• Product Code: JWH
• UDI-Device Identifier: 07613327045666
• UDI-Public: 07613327045666
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2018

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: 02/28/2021
• Device Catalogue Number: 5531G211
• Device Lot Number: LEW760
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 07/23/2018
• 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: 82 YR