MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #2 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5510F201
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.
Event or Problem Description
As reported by rep, who was not present for the event: ¿in performing a left tkr, surgeon requested a press-fit femur.The associate rep who was present took a cemented femur, confirmed it with the operating room (o.R.) staff twice, and showed it to the surgeon.Surgeon implanted the cemented femur without cement.Upon submitting the billing sheet to the rep, rep discovered a press-fit baseplate used with a cemented femur and contacted the associate rep to try to get the correct implant implanted.Patient had been brought out of the o.R.And was awake.The surgeon explained to the patient what had happened.Patient was brought back into the o.R.And the cemented femur was revised to a press-fit femur.
Additional Manufacturer Narrative
An event regarding the surgeon press fitting a cemented device involving a triathlon cemented femoral component was reported.Conclusion: the instructions for use provided with the product indicates components labelled for "cemented use only" are to be implanted with bone cement.Based on the information provided this event is associated with user error and an off label application.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
As reported by rep, who was not present for the event: ¿in performing a left tkr, surgeon requested a press-fit femur.The associate rep who was present took a cemented femur, confirmed it with the o.R.Staff twice, and showed it to the surgeon.Surgeon implanted the cemented femur without cement.Upon submitting the billing sheet to the rep, rep discovered a press-fit baseplate used with a cemented femur and contacted the associate rep to try to get the correct implant implanted.Patient had been brought out of the o.R.And was awake.The surgeon explained to the patient what had happened.Patient was brought back into the o.R.And the cemented femur was revised to a press-fit femur.

• Brand Name: TRIATHLON CR FEM COMP #2 L-CEM
• 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: 7105853
• Report Number: 0002249697-2017-03551
• Device Sequence Number: 1874842
• Product Code: MBH
• UDI-Device Identifier: 07613327040234
• UDI-Public: 07613327040234
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/24/2022
• Device Catalogue Number: 5510F201
• Device Lot Number: CN27T
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 02/09/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 37 YR