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

Catalog Number	5520-B-600
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock on 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
The plastic packaging of the implant was crushed and sterility was questioned.
Additional Manufacturer Narrative
An event regarding blister damage involving a triathlon baseplate was reported.The event was confirmed.Visual evaluation of the returned device packaging confirmed that the blisters in the box were damaged.Medical records received and evaluation: not performed as no patient information was provided for review.A device history review indicated that all devices that were accepted into final stock conformed to specification.A complaint history review indicated that there have been no similar events for the reported lot.Visual inspection confirmed that this damage aligned with the location of the slight damage on the outer box.The investigation concluded that the blisters were damaged however, the root cause could not be determined.A shipment discrepancy report has been initiated by reliability engineering regarding the finished goods shipment has been completed.There is no indication or evidence to suggest the reported event is related to the design or manufacture of the device.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.
Event or Problem Description
The plastic packaging of the implant was crushed and sterility was questioned.

• Brand Name: TRIATHLON PRIM TIB BASEPLATE - 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: 6742262
• Report Number: 0002249697-2017-02279
• Device Sequence Number: 1246669
• Product Code: MBH
• UDI-Device Identifier: 07613327050349
• UDI-Public: 07613327050349
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2017

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: 04/04/2022
• Device Catalogue Number: 5520-B-600
• Device Lot Number: AGZ3UA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 07/25/2017
• Supplement Report FDA Received Date: 11/08/2017
• 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