MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5537-G-413
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hematoma (1884); Injury (2348)
Date of Event	02/23/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other 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.The following devices were also listed in this report: tri ts baseplate size 4; cat# 5521-b-400; lot# frd.Triathlon total knee system offset adapter 6mm; cat# 5570-s-060; lot# m3w40am.Tri press-fit stem 16mm x 100mm; cat# 5565-s-016; lot# m6s43j.Triathlon total knee system offset adapter 4mm; cat# 5570-s-040; lot# m6m13a.Triathlon femoral distal augment 5mm - size 4 left; cat# 5540-a-401; lot# dzjr.Tri press-fit stem 15mm x 100mm; cat# 5565-s-015; lot# m4c20e.Triathlon femoral distal augment 5mm - size 4 left; cat# 5540-a-401; lot# duxj.Tri ts femur sz4 left; cat# 5512-f-401; lot# edil.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.
Event or Problem Description
Based on the medical review for (b)(4), it was reported that post revision rehabilitation was complicated by occurrence of a hematoma in the knee requiring arthroscopic surgical evacuation with debridement on (b)(6) 2012.Most of the hematoma was in the supra patellar pouch plus medial and lateral gutters of the knee.The total knee components were unremarkable and remained in place.
Event or Problem Description
Based on the medical review for pi 2038833, it was reported that post revision rehabilitation was complicated by occurrence of a hematoma in the knee requiring arthroscopic surgical evacuation with debridement on (b)(6) 2012.Most of the hematoma was in the supra patellar pouch plus medial and lateral gutters of the knee.The total knee components were unremarkable and remained in place.
Additional Manufacturer Narrative
An event regarding patient factor involving a triathlon insert was reported.The event was confirmed based on the medical review.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: arthrofibrosis contributed to a severe degree of scar tissue formation post triathlon cr primary knee arthroplasty in (b)(6) 2011 requiring repeated interventions for treatment including manipulation under anaesthesia in (b)(6) 2018, a first knee revision with scar tissue removal plus femoral shortening with exchange of all components for new triathlon ts components in (b)(6) 2012, an arthroscopic removal of hematoma a few weeks later plus another knee revision with removal of exceptionally dense scar tissue plus quadriceps tendon lengthening in feb 2013 while retaining all devices.Residual pain was still present in 2018 although knee functionality appears to have been improved after the second revision.Arthrofibrosis is a procedure-related complication of potentially any knee arthroplasty with sometimes additional patient-related risk factors.A knee twisting trauma with collateral ligament injury in 1974 counts as risk factor for arthrofibrosis.No device-related factors are associated with any of the implanted devices at any time.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there has been 2 other lot referenced relating to the same patient and device.Conclusions: based on the medical review, arthrofibrosis contributed to a severe degree of scar tissue formation post triathlon cr primary knee arthroplasty in (b)(6) 2011 requiring repeated interventions for treatment.Arthrofibrosis is a procedure-related complication of potentially any knee arthroplasty with sometimes additional patient-related risk factors.A knee twisting trauma with collateral ligament injury in 1974 counts as risk factor for arthrofibrosis.No device-related factors are associated with any of the implanted devices at any time.No further investigation for this event is required at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM
• 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: 9354010
• Report Number: 0002249697-2019-03841
• Device Sequence Number: 381912
• Product Code: MBH
• UDI-Device Identifier: 07613327027242
• UDI-Public: 07613327027242
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2020

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: 02/28/2016
• Device Catalogue Number: 5537-G-413
• Device Lot Number: MKD6PY
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 01/09/2020
• 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: 59 YR