MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI PRESS-FIT STEM 17MM X 100MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5565-S-017
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2018
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
There is not a secondary white layer to peel back once on sterile field.Around the edges of the package does not have the white adhesive.
Additional Manufacturer Narrative
An event regarding packaging issue involving a triathlon stem was reported.The event was not confirmed.Conclusions: it was reported that the secondary white layer was missing from the package containing triathlon stem.Also, the package didn't have white adhesive around the edges.The device was not returned.A visual inspection of the picture of the device noted that around the edges of the package don¿t have the white adhesive.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
There is not a secondary white layer to peel back once on sterile field.Around the edges of the package does not have the white adhesive.

• Brand Name: TRI PRESS-FIT STEM 17MM X 100MM
• 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: 7373374
• Report Number: 0002249697-2018-00877
• Device Sequence Number: 11176969
• Product Code: MBH
• UDI-Device Identifier: 07613327026788
• UDI-Public: 07613327026788
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 05/23/2018

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: 01/31/2022
• Device Catalogue Number: 5565-S-017
• Device Lot Number: 0054574D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 05/23/2018
• 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