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

Catalog Number	5630-G-208
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Stryker triathlon size 2 by 8mm thick polyethylene failed to seat in stryker triathlon pkr size 2 base plate.After first polyethylene component was damaged, 4 more polyethylene components failed to seat.It was later reported that the total surgical delay approximately 2 hours with tourniquet in use.Surgeon decided to convert the procedure to a total knee procedure.
Event or Problem Description
Stryker triathlon size 2 by 8mm thick polyethylene failed to seat in stryker triathlon pkr size 2 base plate.After first polyethylene component was damaged, 4 more polyethylene components failed to seat.It was later reported that the total surgical delay approximately 2 hours with tourniquet in use.Surgeon decided to convert the procedure to a total knee procedure.
Additional Manufacturer Narrative
An event regarding seating/locking issues involving a triathlon pkr insert was reported.The event was not confirmed.Method & results: product evaluation and results: review of the device by a material analysis engineer that, ¿damage observed on insert consistent with implantation and explantation processes and common damage modes of uhmwpe.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.¿ clinician review: not performed as this was an intraoperative event.Product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.-complaint history review: no other events were reported for the lot indicated.Conclusions: the event could not be confirmed as the implant was returned damaged and a functional or dimensional inspection could not be conducted.Examination of the device by the material analysis engineer indicated that damage observed is consistent with implantation process.No further investigation for this event is required at this time.If the additional information is received, this investigation will be reopened and re-evaluated.

• Brand Name: TRIATHLON PKR INSERT X3 #2 LM/RL -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: 8160299
• Report Number: 0002249697-2018-04034
• Device Sequence Number: 2126561
• Product Code: HRY
• UDI-Device Identifier: 07613327015843
• UDI-Public: 07613327015843
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 5630-G-208
• Device Lot Number: MNN0WN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 02/05/2019
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 71 YR