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

Model Number 5550-G-339

Device Problem Loss of Osseointegration (2408)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 09/30/2019

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Procedure: the patient underwent left total knee replacement (b)(6) 2016.Patient underwent left total knee revision for mechanical loosening of patella in (b)(6) 2019.Liner and patella exchanged.

Manufacturer Narrative

An event regarding loosening involving a triathlon patella was reported.The event was confirmed through clinician review of the provided medical records.Method & results: -product evaluation and results: not performed as no product was returned for evaluation.-clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: [.] undated x-ray printouts include an ap, lateral and patellar view of the left knee labeled ¿index surgery¿ demonstrating a cemented ps total knee arthroplasty reduced in nominal position.Another ap, lateral and patellar view of the left knee labeled ¿pre-revision¿ demonstrates the femoral and tibial components unchanged with the patellar component disassociated from the host patella with lateral subluxation of the host patella.Another ap, lateral and patellar view of the left knee labeled ¿post- revision¿ shows the femoral and tibial components unchanged with a new cemented patella in situ.The knee is reduced and the components are in nominal position.No clinical or past medical history and no examination of the explanted components are available.Based upon the information available for review, no determination can be made regarding the cause of the failure of fixation of the patellar component after three-and-a-half years in situ in this obese male patient.-product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: the event itself was confirmed through clinician review of the provided medical records who indicated that the patellar component disassociated from the host patella with lateral subluxation of the host patella.The exact cause of the event could not be determined because insufficient information was provided.Further information such as clinical and past medical history as well as examination of the explanted components are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Procedure: the patient underwent left total knee replacement 3/11/2016.Patient underwent left total knee revision for mechanical loosening of patella in 9/30/2019.Liner and patella exchanged.

• Brand Name: TRIATHLON SYMMETRIC X3 PATELLA
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9652530
• MDR Text Key: 177145263
• Report Number: 0002249697-2020-00197
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327014754
• UDI-Public: 07613327014754
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 5550-G-339
• Device Catalogue Number: 5550-G-339
• Device Lot Number: DTVP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 109