MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON ASYM PATELLA A32X10; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5551L320
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	03/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.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.Not available.
Event or Problem Description
The patient underwent a revision of his right medial uni-compartment to a right total knee arthroplasty on (b)(6) 2016.He further alleges that he continues to have pain and loosening of his knee component.He scheduled for a second revision.Sales rep reported a primary revision of a right total knee due to loose tibial tray.No trauma or delay.
Event or Problem Description
The patient underwent a revision of his right medial uni-compartment to a right total knee arthroplasty on (b)(6)2016.He further alleges that he continues to have pain and loosening of his knee component.He scheduled for a second revision.Sales rep reported a primary revision of a right total knee due to loose tibial tray.No trauma or delay.
Additional Manufacturer Narrative
Additional information: date of explant.An event regarding malposition involving a triathlon patella was reported.The event was confirmed.Method & results: -product evaluation and results: not performed as the device was not returned.-clinician review: a medical review noted: ¿the operative report notes, "significant scar tissue debrided.Mild instability varus/valgus.Slight lateral tilt of patella.Slightly oversized patella.Femur maintained patella tracking: some lateral subluxation.Resected 2mm more patella and changed to a smaller component and performed a lateral release ".¿there is no examination of the explanted components, no x-rays or bone scan showing evidence of component loosening, and the operative report describes a need for a saw and osteotome to remove the tibial component, which was described as "well-placed and well aligned", all of which suggest questionable indication for tibial component revision.Patella maltracking and/or overstuffing and arthrofibrosis may have contributed to the symptoms described prior to the revision.There is no evidence that factors related to the total knee arthroplasty components in place, with regard to their design, manufacturing or materials, were responsible for this clinical situation.¿ ¿doctor's hypothesis is that failure to use a ps total knee arthroplasty construct resulted in instability in a revision surgery, which was the likely cause of the symptoms.While i do not necessarily agree with his theory, there is still no evidence of failure of component design, manufacturing or materials responsible for this clinical situation, and the indication for a revision of the tibial component to a long-stem version does not appear justified by convincing evidence of loosening.¿ - product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.-complaint history review: no other events were reported for the lot indicated.Conclusions: the malposition of the patella was confirmed however, the root cause cannot be determined.The consulting clinician indicated, ¿patella maltracking and/or overstuffing and arthrofibrosis may have contributed to the symptoms described prior to the revision.¿ no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON ASYM PATELLA A32X10
• 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: 6817733
• Report Number: 0002249697-2017-02603
• Device Sequence Number: 129762
• Product Code: MBH
• UDI-Device Identifier: 07613327049855
• UDI-Public: 07613327049855
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2018

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: 01/21/2021
• Device Catalogue Number: 5551L320
• Device Lot Number: LEW136
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2017
• Supplement Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 08/24/2017
• Supplement Report FDA Received Date: 07/17/2018
• 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: 50 YR
• Patient Weight: 91