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	Injury (2348); Blood Loss (2597)
Date of Event	07/18/2019
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
As reported "painful total right knee with recurrent internal bleeding in joint".Rep indicated the liner was revised.
Event or Problem Description
As reported "painful total right knee with recurrent internal bleeding in joint".Rep indicated the liner was revised.18 october 2019; update as per medical review.There is an operative report dated (b)(6) 2019 for an open synovectomy with coagulation of soft tissue and change of poly from a #7/9 to a #7/11 cs.Thickened periarticular scar tissue¿ hemosiderin in the synovium¿ changed poly.Uncomplicated surgery.
Additional Manufacturer Narrative
An event regarding arthrofibrosis involving a triathlon insert.The event was confirmed through clinician review of the provided records.Method & results: device evaluation and results: not performed as no product was returned for evaluation.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: there is an operative report dated (b)(6) 2019 for an open synovectomy with coagulation of soft tissue and change of poly from a #7/9 to a #7/11 cs.General anesthesia and tourniquet utilized for two minutes at a time and then released was noted.The operative report notes, ¿¿ thickened periarticular scar tissue ¿ hemosiderin in the synovium ¿ changed poly.Uncomplicated surgery.¿on an (b)(6) 2019 office visit pain was noted to be 2 over 10 and the patient was ¿satisfied with surgery¿.Physical examination revealed mild effusion and a range of motion of from 0° to 95°.Staples were removed and ice and elevation were prescribed.The patient was to return in four weeks.On (b)(6) 2019 the patient returned for an office visit and pain was noted to be 0 and he was doing well.Physical examination revealed no effusion or tenderness.Range of motion was noted to be 0° to 105° and he had a normal gait, without a limp.He was to return in six months.No subsequent follow-up is documented.No x-rays or examination of explanted components are available for review.There is no evidence that the recurrent hemarthrosis in this patient was related to factors associated with implant design, manufacturing or materials.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: a review of the provided medical records and x-rays by a clinical consultant indicated: there is an operative report dated on (b)(6) 2019 for an open synovectomy with coagulation of soft tissue and change of poly from a #7/9 to a #7/11 cs.General anesthesia and tourniquet utilized for two minutes at a time and then released was noted.The operative report notes, ¿¿ thickened periarticular scar tissue ¿ hemosiderin in the synovium ¿ changed poly.Uncomplicated surgery.¿on an (b)(6) 2019 office visit pain was noted to be 2 over 10 and the patient was ¿satisfied with surgery¿.Physical examination revealed mild effusion and a range of motion of from 0° to 95°.Staples were removed and ice and elevation were prescribed.The patient was to return in four weeks.On (b)(6) 2019 the patient returned for an office visit and pain was noted to be 0 and he was doing well.Physical examination revealed no effusion or tenderness.Range of motion was noted to be 0° to 105° and he had a normal gait, without a limp.He was to return in six months.No subsequent follow-up is documented.No x-rays or examination of explanted components are available for review.There is no evidence that the recurrent hemarthrosis in this patient was related to factors associated with implant design, manufacturing or materials.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: 8892495
• Report Number: 0002249697-2019-02846
• Device Sequence Number: 13524472
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2019

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 Expiration Date: 09/30/2021
• Device Catalogue Number: 5531G709
• Device Lot Number: LFG723
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 11/20/2019
• 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: 67 YR
• Patient Weight: 128