MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #3 RM/LL -8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 5630-G-328

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Scar Tissue (2060); Injury (2348)

Event Date 05/31/2017

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: triathlon pkr baseplate #3 rm/ll; cat# 5620-b-302; lot# wssra, triathlon pkr femur #4 rm/ll; cat# 5610-f-402; lot# wbwa, triathlon asym patella a35x10; cat# 5551l350; lot# lfh094.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.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.

Event Description

This pi is for the manipulation under anesthesia of patient's right knee (b)(6) 2017.In performing a medical review for the revision of the patient's right knee on (b)(6) 2017, the following findings were reported.(b)(6) 2017: ¿problems starting early after surgery,¿ residual hemarthrosis, aspiration 3 times, 50-ml blood reportedly removed.(b)(6) 2017: manipulation under anesthesia.(b)(6) 2017: pain, catching on lateral side of knee, drainage performed (25-ml), no infection.(b)(6) 2017: persistent pain with recurrent effusions.30-ml drained, no infection.

Manufacturer Narrative

An event regarding manipulation under anesthetic due to arthrofibrosis involving a triathlon partial insert was reported.The event was confirmed based on clinician review of the medical records provided.Method & results: device evaluation and results: not performed as product remains implanted.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: several factors quite likely have contributed to early failure due to excessive polyethylene bearing wear in this bicondylar knee replacement with mix of devices from two manufacturers.A bleeding complication occurred early after arthroplasty, unrelated to any implanted device, requiring multiple aspirations and certainly in part contributing to the chronic effusions in the knee ultimately requiring both mua for arthrofibrosis after 2-months and synovectomy plus debridement of the knee after 6-months.Excessive bearing wear was present with an unknown cause at this time due to absence of relevant x-ray and/or explant information.Component malposition and/or third-body abrasive wear range high in clinical causes for such problems and can only be evaluated by x-rays that are currently not available.Finally should patient obesity with a bmi of 38 be considered a secondary factor to increase overload conditions from other causes such as discussed.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: a review of the provided medical records and x-rays by a clinical consultant indicated: several factors quite likely have contributed to early failure due to excessive polyethylene bearing wear in this bicondylar knee replacement with mix of devices from two manufacturers.A bleeding complication occurred early after arthroplasty, unrelated to any implanted device, requiring multiple aspirations and certainly in part contributing to the chronic effusions in the knee ultimately requiring both mua for arthrofibrosis after 2-months and synovectomy plus debridement of the knee after 6-months.Excessive bearing wear was present with an unknown cause at this time due to absence of relevant x-ray and/or explant information.Component malposition and/or third-body abrasive wear range high in clinical causes for such problems and can only be evaluated by x-rays that are currently not available.Finally should patient obesity with a bmi of 38 be considered a secondary factor to increase overload conditions from other causes such as discussed.The exact cause of the event could not be determined because insufficient information was provided.Additional information including x-rays and evaluation of the devices are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

This pi is for the manipulation under anesthesia of patient's right knee (b)(6) 2017.In performing a medical review for the revision of the patient's right knee on (b)(6) 2017, the following findings were reported.On (b)(6)2017: ¿problems starting early after surgery,¿ residual hemarthrosis, aspiration 3 times, 50-ml blood reportedly removed.On (b)(6)2017: manipulation under anesthesia.On (b)(6)2017: pain, catching on lateral side of knee, drainage performed (25-ml), no infection.On (b)(6)2017: persistent pain with recurrent effusions.30-ml drained, no infection.

• Brand Name: TRIATHLON PKR INSERT X3 #3 RM/LL -8MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9174569
• MDR Text Key: 162646178
• Report Number: 0002249697-2019-03466
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 07613327015980
• UDI-Public: 07613327015980
• Combination Product (y/n): N
• PMA/PMN Number: K082567
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 5630-G-328
• Device Lot Number: XA17M4
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR