MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 3; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5521-B-300
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported by sales rep, a hair was discovered in the inside packaging of the product.
Additional Manufacturer Narrative
An event regarding a foreign object found in the packaging involving a triathlon baseplate was reported.The event was not confirmed.Method & results: device evaluation and results: the device was received but no hair was returned with the device.Packaging was not returned based on the attached images.Medical records received and evaluation: not performed as the event is not related to patient factors.Device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the event could not be confirmed nor the root cause determined because insufficient information was provided.The root cause was not determined because the attached pictures does not show any hair that was mentioned in event description.
Event or Problem Description
It was reported by sales rep, a hair was discovered in the inside packaging of the product.

• Brand Name: TRI TS BASEPLATE SIZE 3
• 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: 6443396
• Report Number: 0002249697-2017-01054
• Device Sequence Number: 10909632
• Product Code: MBH
• UDI-Device Identifier: 07613327026313
• UDI-Public: (01)07613327026313(11)160616(17)210630(10)VPYWA
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 06/19/2017

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: 06/30/2021
• Device Catalogue Number: 5521-B-300
• Device Lot Number: VPYWA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/01/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2017
• Supplement Report FDA Received Date: 06/19/2017
• 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
• Patient Age: 78 YR