MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number	5515-F-301
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Not available.
Event or Problem Description
It was reported that when the circulator was passing the 3 left ps cemented (triathlon) femur to the surgical tech, the implant could not be removed from the inner packaging.In order to avoid any sterilization concerns, the surgeon had a new implant opened instead.There were no surgical delays, and no adverse affects to the patient.This was during a primary surgery.
Additional Manufacturer Narrative
An event regarding packaging issue involving a triathlon femoral component was reported.The event was not confirmed.Device evaluation: the device was not returned.However, a visual inspection of the picture of the device noted that inner packaging was stuck on the posterior side of the femoral component.Apart from this the implant looks unremarkable.(refer attached images).Clinician review: not performed as medical records were not received for review with a clinical consultant.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there have been no similar previous reported events for this lot id.Conclusions: a visual inspection of the device noted that inner packaging was stuck on the posterior side of the side of the femoral component.However, the event could not be confirmed nor the root cause determined as the product was not returned.No further investigation is required at this time.If additional information or the device becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that when the circulator was passing the 3 left ps cemented (triathlon) femur to the surgical tech, the implant could not be removed from the inner packaging.In order to avoid any sterilization concerns, the surgeon had a new implant opened instead.There were no surgical delays, and no adverse affects to the patient.This was during a primary surgery.

• Brand Name: TRIATHLON PS FEM COMPONENT, CEMENTED
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6746022
• Report Number: 0002249697-2017-02298
• Device Sequence Number: 16349026
• Product Code: MBH
• UDI-Device Identifier: 07613327050356
• UDI-Public: 07613327050356
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 09/26/2017

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: 10/14/2020
• Device Catalogue Number: 5515-F-301
• Device Lot Number: SYU4SZO4
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2017
• Supplement Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 07/26/2017
• Supplement Report FDA Received Date: 09/26/2017
• 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