MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #7 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531G709
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	07/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 cr fem comp #8 r-cem; 5510f802; lot# unknown.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 right knee was revised due to pain.Patient was converted from a cr to a ps construct.
Event or Problem Description
It was reported that patient's right knee was revised due to pain.Patient was converted from a cr to a ps construct.
Additional Manufacturer Narrative
An event regarding instability involving a triathlon insert was reported.The event was confirmed through clinician review of the medical records provided.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: a review of the provided medical records by a clinical consultant indicated: no x-rays are available for review and there is no examination of the explanted components.The description of instability with symptoms within a year of total knee arthroplasty with x-rays described as ¿nominal¿ suggests a soft tissue imbalance that was corrected with an increased constraint of the implant components.There is no evidence this clinical situation was related to factors of manufacturing or material of the initial implants.Product history review: not performed as no lot information was provided.Complaint history review: not performed as no lot information was provided.Conclusions: the patient was revised due to instability.The medical review indicated: no x-rays are available for review and there is no examination of the explanted components.The description of instability with symptoms within a year of total knee arthroplasty with x-rays described as ¿nominal¿ suggests a soft tissue imbalance that was corrected with an increased constraint of the implant components.There is no evidence this clinical situation was related to factors of manufacturing or material of the initial implants.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: X3 TRIATHLON CS INSERT #7 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7797781
• Report Number: 0002249697-2018-02572
• Device Sequence Number: 2218044
• Product Code: MBH
• UDI-Device Identifier: 07613327046007
• UDI-Public: 07613327046007
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2018

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 Catalogue Number: 5531G709
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 11/16/2018
• 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: 74 YR
• Patient Weight: 78