MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #2 RM/LL -8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	5630-G-228
Medical Device Problem Codes	Crack (1135); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The insert did not seat properly on the tibial tray and it broke during insertion.
Additional Manufacturer Narrative
An event regarding damage involving an triathlon insert was reported.The event was confirmed.Method & results: device evaluation and results: damage observed in the insert consistent with contact against a hard object and explantation.Visual inspection of the returned device confirms that the device was damaged on both sides at the time of implantation.Machine markings are still present.Medical records received and evaluation: there is no indication that patient factors contributed to the reported event.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: visual inspection of the returned device confirms that the device was damaged on both sides at the time of implantation.Material analysis indicated damage observed in the insert consistent with contact against a hard object and explantation.No further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened.
Event or Problem Description
The insert did not seat properly on the tibial tray and it broke during insertion.

• Brand Name: TRIATHLON PKR INSERT X3 #2 RM/LL -8MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6503767
• Report Number: 0002249697-2017-01296
• Device Sequence Number: 624005
• Product Code: HRY
• UDI-Device Identifier: 07613327015904
• UDI-Public: (01)07613327015904(11)161004(17)211031(10)2L5YVW
• Combination Product (Y/N): N
• PMA/510(K) Number: K082567
• 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): 06/21/2017

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: 10/31/2021
• Device Catalogue Number: 5630-G-228
• Device Lot Number: 2L5YVW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2017
• Supplement Report FDA Received Date: 06/21/2017
• 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