MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5532-G-619

Device Problems Material Deformation (2976); Naturally Worn (2988)

Patient Problems Cyst(s) (1800); Injury (2348); Inadequate Osseointegration (2646); Fibrosis (3167)

Event Date 05/14/2012

Event Type  Injury  

Manufacturer Narrative

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.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.Device not available.

Event 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.Burnishing around the ps post, posteriorly and media-lateral regions from contact with the femoral component.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8229280
• MDR Text Key: 132482674
• Report Number: 0002249697-2019-00117
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327046380
• UDI-Public: 07613327046380
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2013
• Device Catalogue Number: 5532-G-619
• Device Lot Number: XE7MNE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR