MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #7 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531G711
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	12/06/2012
Type of Reportable Event	Serious Injury
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.The following devices were also listed in this report: triathlon cr fem comp #6 r-cem, 5510f602, s9n9r.Triathlon prim cem fxd bplt #7, 5520b700, s9sxb.Dura duration all poly pat lg, 6642-2-150, 396455.Simplex p speedset full dose 1 pack, 6192-1-001, djt017.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Not returned.
Event or Problem Description
Patient called stating he had a right knee replacement on (b)(6) 2012.He started experiencing discomfort in 2017.
Event or Problem Description
Patient called stating he had a right knee replacement on (b)(6) 2012.He started experiencing discomfort in 2017.
Additional Manufacturer Narrative
An event regarding pain involving a triathlon insert was reported.The event was confirmed by medical review.Method & results: device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: "it was reported that a patient had right knee replacement on (b)(6) 2012.He started experiencing discomfort in 2017.He was informed by a surgeon that the instruments used to implant his tka were part of a recall.No other information pertinent to the patients complaint of pain were available for review.Review of these records confirms the patient underwent a primary cemented tka, the root cause of the pain that the patient developed in 2017 cannot be determined as insufficient information was available.The implants and instrumentation involved in the patients tka were not involved in a recall.Device history review: review of the product history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: it was reported that the patient was experiencing discomfort.A review of the available medical records by the consulting clinician noted that, "review of these records confirms the patient underwent a primary cemented tka, the root cause of the pain that the patient developed in 2017 cannot be determined as insufficient information was available.The implants and instrumentation involved in the patients tka were not involved in a recall." the root cause can not be determined as insufficient information was available.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: X3 TRIATHLON CS INSERT #7 11MM
• 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: 7960467
• Report Number: 0002249697-2018-03306
• Device Sequence Number: 1487683
• Product Code: MBH
• UDI-Device Identifier: 07613327046038
• UDI-Public: 07613327046038
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: 5531G711
• Device Lot Number: LBY191
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 12/28/2018
• 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
• Patient Age: 63 YR
• Patient Weight: 77