MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A PS BEADED #8R; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number	5516F802
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2018
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
Femoral implant would not fully seat on the femur after we saw the trial completely seat onto the bone.The surgeon opted to used a cemented femoral component instead of the pa femur.
Event or Problem Description
Femoral implant would not fully seat on the femur after we saw the trial completely seat onto the bone.The surgeon opted to used a cemented femoral component instead of the pa femur.
Additional Manufacturer Narrative
An event regarding a size/fir issue involving a triathlon femoral component was reported.The event was not confirmed.Method & results: -product evaluation and results: one femoral component with catalog number 5516-f-802 and lot code ej78h was returned without its packaging in a plastic bag for evaluation.Multi directional scratches are visible on the bearing surface of the femoral component.The pa (peri-apatite) coating on the fixation side of the femoral component around the ps box appears smudged.This is consistent with the surgeon attempting to implant and subsequent post explantation/handling damage.Dimension inspection was performed on the returned device.The device is dimensionally within specification.-clinician review: a review of the provided medical records by a clinical consultant indicated: issues with non-standard femoral bone properties have contributed to the impossibility of triathlon ps pa-coated femoral component placement during final assembly requiring conversion to a similar type cemented component with no further issues other than some surgical delay.-product 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: one femoral component with catalog number 5516-f-802 and lot code ej78h was returned without its packaging in a plastic bag for evaluation.Multi directional scratches are visible on the bearing surface of the femoral component.The pa (peri-apatite) coating on the fixation side of the femoral component around the ps box appears smudged.This is consistent with the surgeon attempting to implant and subsequent post explantation/handling damage.Dimension inspection was performed on the returned device.The device is dimensionally within specification.(triathlon femoral ps inspection guide sheet -qsr 732 attached).A review of the provided medical records by a clinical consultant indicated: issues with non-standard femoral bone properties have contributed to the impossibility of triathlon ps pa-coated femoral component placement during final assembly requiring conversion to a similar type cemented component with no further issues other than some surgical delay.

• Brand Name: TRIATHLON P/A PS BEADED #8R
• 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: 8069442
• Report Number: 0002249697-2018-03724
• Device Sequence Number: 2190662
• Product Code: MBH
• UDI-Device Identifier: 07613327040890
• UDI-Public: 07613327040890
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: 08/30/2019
• Device Catalogue Number: 5516F802
• Device Lot Number: EJ78H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Initial Date Received by Manufacturer: 10/16/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 11/14/2018
• 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: 76 YR