MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE4 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531G411
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
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 similar events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Primary procedure, right knee.It was reported that when the implant was opened, black specks were observed on the device.All but one was able to be wiped off, the one remaining seems to be infused in the poly.Due to sterility concerns, the device was not used.A second device was immediately available and surgery was completed successfully with no delay.Rep reported that the device and packaging are available for return.No further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
An event regarding black specks on a triathlon insert component were reported.The reported black spots which could be wiped off could not be confirmed or further evaluated, however, there was a black speck which appeared embedded in the poly material which was confirmed.Method & results: device evaluation and results: a material analysis has been performed.The report concluded that the particle was observed to be embedded in the polyethylene surface.In order to identify the particle eds analysis was performed on different areas of the particle.The reported ¿black specks¿ in pi were confirmed after visual examination.Characterization of the two particles with optical and electron microscopy, identified the material as an inclusion in the polyethylene.Eds analysis identified the inclusions to consistent of grey matrix comprising of c, ti and ca with dark al particles embedded in the grey matrix.Clinician review: 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.Conclusion: the reported ¿black specks¿ in pi were confirmed after visual examination.Characterization of the two particles with optical and electron microscopy, identified the material as an inclusion in the polyethylene.Eds analysis identified the inclusions to consistent of grey matrix comprising of c, ti and ca with dark al particles embedded in the grey matrix.The manufacturing cell quality and manufacturing engineers have raised nc to evaluate the root cause of the event.The investigation concluded: the affected part was returned to stryker limerick for further review, and the part underwent material analysis.The result of this analysis identified the foreign matter as inclusions within the raw material.This information was reviewed by the raw material vendor, meditech, who confirmed that the reported images and material analysis was indicative of an inclusion in the raw material.No containment will be applied to this batch or this product as this issue is considered to be isolated to one piece from trace code lot: ljb184.
Event or Problem Description
Primary procedure, right knee.It was reported that when the implant was opened, black specks were observed on the device.All but one was able to be wiped off, the one remaining seems to be infused in the poly.Due to sterility concerns, the device was not used.A second device was immediately available and surgery was completed successfully with no delay.Rep reported that the device and packaging are available for return.No further information will be released by the hospital or surgeon.

• Brand Name: X3 TRIATHLON CS INS SIZE4 11MM
• 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: 8804337
• Report Number: 0002249697-2019-02601
• Device Sequence Number: 326643
• Product Code: MBH
• UDI-Device Identifier: 07613327045789
• UDI-Public: 07613327045789
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 5531G411
• Device Lot Number: LJB184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 10/02/2019
• 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: Other
• Patient Age: 68 YR