MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 2. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5537-G-213
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	06/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The following devices were also listed in this report: tri ts femur sz3 right; cat# 5512-f-302 ; lot# usg3.Tri ts baseplate size 2; cat# 5521-b-200; lot# b9x3sa.Tri cemented stem 12mmx50mm; cat# 5560-s-112; lot# 0075449m.Triathlon femoral distal augment 10mm - size 3 right; cat# 5541-a-302; lot# aoe7y.Triathlon femoral distal augment 5mm - size 3 right; cat# 5540-a-302; lot# bgg4i.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It was reported that the patient's right knee was revised due to suspected infection (unknown if infection was clinically confirmed or identified).The patient's entire knee construct was removed and a temporary spacer placed.
Event or Problem Description
It was reported that the patient's right knee was revised due to suspected infection (unknown if infection was clinically confirmed or identified).The patient's entire knee construct was removed and a temporary spacer placed.Rep provided an operative report and office visit notes, and reported that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event an event regarding infection involving a triathlon insert was reported.The event was confirmed by 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: knee aspiration may provide the final diagnosis and although no results of bacteriological studies were reported, the high infectious cell count in the knee aspirate is adequate support for the infection diagnosis in combination with all positive lab infection parameters.Multiple knee revision surgeries for instability in only a few years time have contributed to increased infection risk in combination with patient¿s obesity bmi=34 as moderate infection risk factor, all contributing to an active arthroplasty infection requiring a two-stage approach in treatment with all devices removed in a first stage combined with antibiotic spacer implantation.Given the recent surgery, no information is available at this time about future developments.Infection is primarily a procedure-related complication with sometimes additional patient-related risk factors.No device-related factors are associated with any of the implanted devices, consistent with type of failure.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 have been no other similar events for the lot referenced.There have been no other similar events for the sterile lot referenced.Conclusions: based on the medical review, the high infectious cell count in the knee aspirate is adequate support for the infection diagnosis in combination with all positive lab infection parameters.Multiple knee revision surgeries for instability in only a few years time have contributed to increased infection risk in combination with patient¿s obesity bmi=34 as moderate infection risk factor, all contributing to an active arthroplasty infection requiring a two-stage approach in treatment with all devices removed in a first stage combined with antibiotic spacer implantation.Given the recent surgery, no information is available at this time about future developments.Infection is primarily a procedure-related complication with sometimes additional patient-related risk factors.No device-related factors are associated with any of the implanted devices, consistent with type of failure.No further investigation is required at this time.If additional information becomes available, this investigation will be reopened.

• Brand Name: NO 2. 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: 8753114
• Report Number: 0002249697-2019-02491
• Device Sequence Number: 1926187
• Product Code: MBH
• UDI-Device Identifier: 07613327027051
• UDI-Public: 07613327027051
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2019

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: 06/30/2020
• Device Catalogue Number: 5537-G-213
• Device Lot Number: YX0T25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 09/02/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 09/30/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 94