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

Catalog Number	5510F402
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An event regarding pack damage involving a triathlon femoral component was reported.The event was confirmed by visual inspection of the returned product.Method & results: device evaluation and results: one unit carton containing its outer/ inner blister and device was returned for evaluation.Severe compression and indentation lines are visible on the unit carton with the opening flap out of shape completely.Compression and wear is also visible on the corners of the unit carton.The outer blister was returned with the tyvek lid still attached.One side flange is broken away from the outer blister allowing the tyvek to be peeled back as it is still attached.There is evidence of a good seal on the three remaining sides of the outer blister.-clinician review: not performed as no medical records were provided.The event is related to a packaging issue and no adverse consequences to the patient were reported.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 lot referenced.Conclusion: based on the visual inspection of the returned product the investigation concluded that the packaging damage was most likely caused by incorrect/excessive handling prior to opening of the product whereby the unit carton may have been compressed and/or dropped from a height causing the damage to the carton.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
During surgery, the nurse was opening the implants and noticed the inner plastic box of the femoral implant (b)(4) was damaged and therefore questioned the sterility.Another implant from consignment stock was used to complete the case.

• Brand Name: TRIATHLON CR FEM COMP #4 R-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: 8190262
• Report Number: 0002249697-2018-04109
• Device Sequence Number: 1300338
• Product Code: MBH
• UDI-Device Identifier: 07613327040289
• UDI-Public: 07613327040289
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/21/2018

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: 08/31/2022
• Device Catalogue Number: 5510F402
• Device Lot Number: CYJ2E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/21/2018
• 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