MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON STEM EXTENDER 25MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5571-S-025
Medical Device Problem Codes	Corroded (1131); Material Deformation (2976)
Health Effect - Clinical Codes	Cyst(s) (1800); Injury (2348); Inadequate Osseointegration (2646); Fibrosis (3167)
Date of Event	05/14/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Letter received from patient's lawyers advising the stryker ts triathlon knee replacement is "defective and materially contributed to.On going left lower limb problems including the development of a pseudo-tumour".Patient is reports left knee problems following surgery on the (b)(6) 2012.Please see communication log for details regarding additional information.As per op report: comments.Triathlon ts cemented revision knee from an (b)(6) year old male revised after 4 years due to osteolysis and alval (pseudotumour) is presented for analysis.High activity level and medial bone loss around the tibial component are considered contributory factor to failure of the device.Femoral component: a combination of bone and fibrous tissue onto cement mantle indicating a well fixed components - numerous longitudinal scratches on bearing surface threaded boss covered with organic material and showing wear on the surface in contact with stem extender (fig.1).Femoral stem extender: corrosion and wear in the base of threaded trunnion from uneven engagement with femoral component boss covered with organic material (fig.2).Femoral stem: wear in the base of threaded trunnion from uneven engagement with femoral extender tibia baseplate: polished cement surface, indicative of micromotion, postero-medially bone tissue still attached to the cement mantle, anteriorly severe fretting corrosion of the surface of the boss as well as corrosion deposits in the threaded boss in contact with stem trunnion.Tibial stem: component was loose and removed from the baseplate manually gross fretting and corrosion in the trunnion: stem surface (inset, fig.4), and in the trunnion threads (fig.5) polyethylene (pe) insert: slight wear on the bearing surface, mostly scratching and burnishing around the ps post, posteriorly and media-lateral regions from contact with the femoral component.

• Brand Name: TRIATHLON STEM EXTENDER 25MM
• 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: 8229580
• Report Number: 0002249697-2019-00118
• Device Sequence Number: 2070070
• Product Code: MBH
• UDI-Device Identifier: 07613327014976
• UDI-Public: 07613327014976
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2019

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 Catalogue Number: 5571-S-025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 01/08/2019
• 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; Required Intervention
• Patient Age: 58 YR