MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI RM/LL TIB AUG SZ5 5MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5545-A-502
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
During surgery the surgeon noticed that the tibial augment could not be fixed to the implant.There was a 15 min surgical delay when looking for a new device.Patient not affected in any other way.
Additional Manufacturer Narrative
An event regarding assembly issue involving an triathlon augment was reported.The event was not confirmed.Device evaluation and results: a functional inspection found the device to be fully functional.The returned tibial augment was mated with a triathlon baseplate, catalog 5521-b-500 lot ao34ba, from finished goods and the locking screw on the augment was able to be locked in the baseplate.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced.Conclusions: the event could not be confirmed as the reported event could not be duplicated.The functional inspection found the device to be fully functional as the locking was screw was able to lock into the triathlon baseplate.No further investigation for this event is possible at this time.
Event or Problem Description
During surgery the surgeon noticed that the tibial augment could not be fixed to the implant.There was a 15 min surgical delay when looking for a new device.Patient not affected in any other way.

• Brand Name: TRI RM/LL TIB AUG SZ5 5MM
• 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: 6659263
• Report Number: 0002249697-2017-01966
• Device Sequence Number: 57202
• Product Code: MBH
• UDI-Device Identifier: 07613327026443
• UDI-Public: 07613327026443
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• 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): 09/12/2017

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: 10/25/2021
• Device Catalogue Number: 5545-A-502
• Device Lot Number: ERDKD0A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2017
• Initial Date Received by Manufacturer: 05/24/2017
• Supplement Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 06/21/2017
• Supplement Report FDA Received Date: 09/12/2017
• 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: 80 YR
• Patient Weight: 60