MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #3R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5517F302
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2018
Type of Reportable Event	Serious Injury
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 events for the reported lot.There have been no other events for the reported lot.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Primary right tka.It was reported that upon opening the implant, some whitish foreign material was observed to be adhered to the waist of the implant.Rep was present for the procedure and personally witnessed the foreign matter.Rep has also retained all packaging and provided pictures of the implant and outer box.The device is available for return having not been cleaned in any way.No surgical delay was caused as another implant was opened and made ready while the surgeon was making his cuts.The implant sticker did not get placed on the implant sheet.
Additional Manufacturer Narrative
Additional information: device evaluated by mfg.An event regarding foreign matter (white stain) involving a triathlon femoral component was reported.The event was confirmed by visual inspection.Method & results: device evaluation and results: a white stain was observed on one isolated area of the polished surface of the returned femoral component.Material analysis concluded that the staining on the bearing surface was attributed to residue from the pa coating.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: the material analysis reported indicated that characterisation using stero microscopy and electron miscroscopy confirmed staining on the bearing surface and on peri apatite (pa) coated surface.The staining on femoral component was attributed to excess residue of pa coating on bearing surface of the femoral component.An nc was initiated by the pa cell for the residue of pa on the femoral component.The nc found that while the excess residue was against specification, (b)(4).Therefore this does not represent a systemic issue.Further, the severity rating is s1, meaning minimal risk to the patient.No further investigation is possible at this time.
Event or Problem Description
Primary right tka.It was reported that upon opening the implant, some whitish foreign material was observed to be adhered to the waist of the implant.Rep was present for the procedure and personally witnessed the foreign matter.Rep has also retained all packaging and provided pictures of the implant and outer box.The device is available for return having not been cleaned in any way.No surgical delay was caused as another implant was opened and made ready while the surgeon was making his cuts.The implant sticker did not get placed on the implant sheet.

• Brand Name: TRIATHLON P/A CR BEADED #3R
• 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: 7577865
• Report Number: 0002249697-2018-01737
• Device Sequence Number: 13511170
• Product Code: MBH
• UDI-Device Identifier: 07613327040951
• UDI-Public: 07613327040951
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 07/31/2018

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: 01/31/2023
• Device Catalogue Number: 5517F302
• Device Lot Number: CEH6R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 07/31/2018
• 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: Other
• Patient Age: 58 YR