MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #2 9MM; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number	5531G209
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	02/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
Event or Problem Description
It was reported that the patient's left knee was revised after patient complaint of pain, redness, and irritation.Surgeon suspected acute infection and performed an irrigation and debridement with poly swap (it is unknown if infection was confirmed by pathology, infecting microorganism not identified).A 2x9 cs insert was exchanged for the same catalog number.

• Brand Name: X3 TRIATHLON CS INSERT #2 9MM
• Common Device Name: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8379370
• Report Number: 0002249697-2019-01224
• Device Sequence Number: 344760
• Product Code: MBH
• UDI-Device Identifier: 07613327045659
• UDI-Public: 07613327045659
• 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: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/28/2019

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 Catalogue Number: 5531G209
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 02/28/2019
• 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: 63 YR
• Patient Weight: 66