MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #3 PS INSERT 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5532P311
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/12/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.
Event or Problem Description
It was reported by the attorney, that the patient underwent a right total knee arthroplasty on (b)(6) 2012 where shape match cutting guides were used and a triathlon knee system was implanted.It is unknown if the patient has undergone revision surgery at this time.Update via conversation with legal department july 30, 2019: the patient has complained of pain but does not want to pursue surgical intervention at this time.
Additional Manufacturer Narrative
The following devices were also listed in this report: triathlon ps fem component, cemented; cat# 5515-f-302; lot# hhiua triathlon prim tib baseplate - cemented; cat# 5520-b-300; lot# gbgmd triathlon sym patella s29x8mm; cat# 5550l298; lot# lcx835 simplex p full dose 1 pack; cat# 6191-1-001; lot# rft094 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It was reported by the attorney, that the patient underwent a right total knee arthroplasty on (b)(6) 2012 where shapematch cutting guides were used and a triathlon knee system was implanted.It is unknown if the patient has undergone revision surgery at this time.Update via conversation with legal department july 30, 2019: the patient has complained of pain but does not want to pursue surgical intervention at this time.

• Brand Name: TRIATHLON #3 PS INSERT 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: 8890766
• Report Number: 0002249697-2019-02833
• Device Sequence Number: 227213
• Product Code: MBH
• UDI-Device Identifier: 07613327042665
• UDI-Public: 07613327042665
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/14/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/30/2017
• Device Catalogue Number: 5532P311
• Device Lot Number: LCZ154
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 08/14/2019
• 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: Other
• Patient Age: 66 YR