MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5520-B-600
Medical Device Problem Codes	Device Packaging Compromised (2916); Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2017
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.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that while a right tka was being performed, implant was opened.The inner blister tyvek was adhered to the outer blister tyvek, and the foam covering the implant was adhered to the inner blister.Due to sterility concern, surgeon elected to not use the implant.Another implant was immediately available and there was no surgical delay.Procedure was completed successfully with no harm to patient.Rep has all packaging except the outer box, and will be providing pictures.
Additional Manufacturer Narrative
An event regarding alleged "packaging issue" involving a triathlon baseplate was reported.The event was not confirmed.Device evaluation: could not be performed as the device was not returned.Medical records received and evaluation: not performed as medical records were not provided for review.A device history review confirmed all devices accepted into finished goods conformed to specification.No other events were reported for the lot indicated.The event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
Event or Problem Description
It was reported that while a right tka was being performed, implant was opened.The inner blister tyvek was adhered to the outer blister tyvek, and the foam covering the implant was adhered to the inner blister.Due to sterility concern, surgeon elected to not use the implant.Another implant was immediately available and there was no surgical delay.Procedure was completed successfully with no harm to patient.Rep has all packaging except the outer box, and will be providing pictures.

• Brand Name: TRIATHLON PRIM TIB BASEPLATE - CEMENTED
• 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: 7104737
• Report Number: 0002249697-2017-03545
• Device Sequence Number: 19028288
• Product Code: MBH
• UDI-Device Identifier: 07613327050349
• UDI-Public: 07613327050349
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 02/27/2018

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: 10/31/2022
• Device Catalogue Number: 5520-B-600
• Device Lot Number: A4V3XA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 02/27/2018
• 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