MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #4 R-CEM; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number	5510F402
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Primary procedure, right knee.It as reported that when the device was opened in the field, white particulate matter was seen on the device.Cement was used during the procedure but had not been opened at time of discovery.A second device was obtained from hospital inventory and used to complete the procedure.Rep reported a surgical delay of approximately 5 minutes with no tourniquet use.
Additional Manufacturer Narrative
An event regarding foreign matter (white matter) involving a triathlon femoral component was reported.The event was confirmed by visual inspection of the photograph provided.Method & results: device evaluation and results: a photograph of the femoral component in the o.R.Was provided which depicts a white foreign matter/stain on the blasted surface of the component, near the inter-condylar notch.The femoral component (5510f402, triathlon cr fem comp #4 r-cem, lim, cat: 5510f402, lot: dal3e) was received for inspection.The product was not decontaminated upon receipt and was adequately labelled as such.The foreign matter observed on the initial image provided was no longer visible.When queried with the sales rep he indicated that the substance was washed away before they handed it off to him.The device appeared unremarkable with no evidence of foreign matter contamination.Medical records received and evaluation: not performed as no medical records were provided.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 reported lot referenced.Conclusion: a photograph of the femoral component in the o.R.Was provided which depicts a white foreign matter/stain on the blasted surface of the component, near the inter-condylar notch.The femoral component (5510f402, triathlon cr fem comp #4 r-cem, lim, cat: 5510f402, lot: dal3e) was received for inspection.The product was not decontaminated upon receipt and was adequately labelled as such.The foreign matter observed on the initial image provided was no longer visible.When queried with the sales rep he indicated that the substance was washed away before they handed it off to him.The device appeared unremarkable with no evidence of foreign matter contamination.No further testing or evaluation of the returned device is possible as the foreign matter contamination was removed from the component by the customer, therefore the nature of the foreign matter or a potential source of the matter cannot be determined.No further investigation is possible at this time.
Event or Problem Description
Primary procedure, right knee.It as reported that when the device was opened in the field, white particulate matter was seen on the device.Cement was used during the procedure but had not been opened at time of discovery.A second device was obtained from hospital inventory and used to complete the procedure.Rep reported a surgical delay of approximately 5 minutes with no tourniquet use.

• Brand Name: TRIATHLON CR FEM COMP #4 R-CEM
• 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: 8064620
• Report Number: 0002249697-2018-03700
• Device Sequence Number: 2575413
• Product Code: MBH
• UDI-Device Identifier: 07613327040289
• UDI-Public: 07613327040289
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/08/2019

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: 02/28/2023
• Device Catalogue Number: 5510F402
• Device Lot Number: DAL3E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Received by Manufacturer: 10/16/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 01/08/2019
• 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: 66 YR