MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #4R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5517F402
Medical Device Problem Codes	Fitting Problem (2183); Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Surgeon was performing a right mako total knee on a (b)(6) woman.Surgeon made all his knee cuts according to plan and decided he wanted to press fit the femoral and tibial components and cement the patella.Surgeon impacted a triathlon tritanium press fit tibial baseplate onto the tibia without any issue.He then proceeded to impact a size 4 right press fit triathlon cr femur onto the patient's femur.After his impaction of the femur, the surgeon brought to our attention that the femoral component was loose and not ideal for press fitting.At this point, the surgeon removed the press fit femoral component and moved forward with a #4 right cr cemented femoral component.This femoral component was successfully impacted onto the femur and he proceeded to cement the patella.Once the cement was dry an insert was implanted and the knee was closed.
Event or Problem Description
Surgeon was performing a right mako total knee on a (b)(6) year old woman.Surgeon made all his knee cuts according to plan and decided he wanted to press fit the femoral and tibial components and cement the patella.Surgeon impacted a triathlon tritanium press fit tibial baseplate onto the tibia without any issue.He then proceeded to impact a size 4 right press fit triathlon cr femur onto the patient's femur.After his impaction of the femur, the surgeon brought to our attention that the femoral component was loose and not ideal for press fitting.At this point, the surgeon removed the press fit femoral component and moved forward with a #4 right cr cemented femoral component.This femoral component was successfully impacted onto the femur and he proceeded to cement the patella.Once the cement was dry an insert was implanted and the knee was closed.
Additional Manufacturer Narrative
An event regarding size/fit (press-fit) issue involving a triathlon femoral component was reported.The event was not confirmed.Method & results: -device evaluation and results: the femoral component was returned in a plastic bag for evaluation.No packaging was returned for the device.Scratches on the bearing surface of the femoral component are consistent with attempted implantation, explanation damage and subsequent post explant/handling damage.The internal fixation surface appears unremarkable.Dimensional inspection was performed as per (b)(4) (triathlon femoral cr inspection guide sheet).It was confirmed that the returned part met the manufacturing specification.-medical records received and evaluation: not performed as medical records were not 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.Conclusions: an event regarding size/fit (press-fit) issue involving a triathlon femoral component was reported.The manufacturing cell examined the part against triathlon femoral cr inspection guide sheet ((b)(4)).It was confirmed that the returned part meets the manufacturing specifications.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

• Brand Name: TRIATHLON P/A CR BEADED #4R
• 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: 7011833
• Report Number: 0002249697-2017-03249
• Device Sequence Number: 13840069
• Product Code: MBH
• UDI-Device Identifier: 07613327040944
• UDI-Public: 07613327040944
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 01/11/2018

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: 11/23/2021
• Device Catalogue Number: 5517F402
• Device Lot Number: BPY3P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 01/11/2018
• 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: 63 YR