MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5537-G-511
Medical Device Problem Codes	Crack (1135); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994)
Date of Event	01/01/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
It was reported by patient's wife, patient had a right tka on 2010 (approx).Within a year of the surgery patient started to experience pain and swelling.The patient followed up with his surgeon and was told he had an infection and was revised on 2012 (approx).The patient was implanted with an antibiotic spacer and approx 3-5 months later the patient was implanted.Early this year the patient started to experience pain.On (b)(6) 2021 the patient followed up with his surgeon where an x-ray was taken and was told that his implant was cracked.The surgeon recommended revision.Patient would like some assistance with medical bills and revision surgery.Patient is seeking compensation.This pi is for revision of primary due to infection.
Event or Problem Description
It was reported by patient's wife, patient had a right tka on 2010 (approx).Within a year of the surgery patient started to experience pain and swelling.The patient followed up with his surgeon and was told he had an infection and was revised on 2012 (approx).The patient was implanted with an antibiotic spacer and approx 3-5 months later the patient was implanted.Early this year the patient started to experience pain.On (b)(6) 2021 the patient followed up with his surgeon where an x-ray was taken and was told that his implant was cracked.The surgeon recommended revision.Patient would like some assistance with medical bills and revision surgery.Patient is seeking compensation.This pi is for revision of primary due to infection.
Additional Manufacturer Narrative
Reported event: an event regarding infection involving an unknown implant knee was reported.The event was confirmed via medical review.Method & results: -device evaluation and results: not performed as the device was not returned.-clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: ¿laboratory tests performed on june 4, 2012 reveal an abnormal cbc and a very high c-reactive protein at 4.8, with a normal of less than 0.80.Cell count revealed over 9000 white blood cells with cloudy fluid.There were no organisms seen and final culture was negative.Sedimentation rate was 69 with a normal of up to 11.This was taken on september 6, 2012.On that same day a c-reactive protein was performed which was 7.4.[¿] this inquiry reports a total knee implant that initially failed due to infection.[¿] i can confirm that this event took place since i was able to review the x-rays and photographs and operation notes.Regarding the possible root cause of this event, infection can be caused by contamination at the time of original surgery or possibly by hematogenous spread from a distal focus.¿ -device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: the infection event was confirmed through review of the provided medical records by a clinical consultant.However, the medical records did not have sufficient information to classify the type of infection as the clinical consultant notes, ¿laboratory tests performed on (b)(6) 2012 reveal an abnormal cbc and a very high c-reactive protein at 4.8, with a normal of less than 0.80.Cell count revealed over 9000 white blood cells with cloudy fluid.There were no organisms seen and final culture was negative.¿ all stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance with applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Additional information including pathology reports and return of the device is needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Additional Manufacturer Narrative
The following devices were also listed in this report: triathlon ps fem component, cemented; cat # 5515-f-602; lot # aenr, triathlon asymmetric x3 patella; cat # 5551-g-350; lot # 956v, tri ts baseplate size 5; cat # 5521-b-500; lot # bhat, simplex p speedset full dose 1 pack; cat # 6192-1-001; lot # dcr007.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding infection involving a triathlon insert was reported.The event was confirmed via medical review.Method & results: product evaluation and results: not performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: [.] conclusion of assessment: this inquiry reports a total knee implant that initially failed due to infection.[.] i can confirm that this event took place since i was able to review the x-rays and photographs and operation notes.Regarding the possible root cause of this event, infection can be caused by contamination at the time of original surgery or possibly by hematogenous spread from a distal focus.[.] product history review: review of the device history records indicate 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 lot or sterile lot referenced.Conclusion: the infection event was confirmed through review of the provided medical records by a clinical consultant.All stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.The exact cause of the event could not be determined from the information provided.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.
Event or Problem Description
It was reported by patient's wife, patient had a right tka on 2010 (approx).Within a year of the surgery patient started to experience pain and swelling.The patient followed up with his surgeon and was told he had an infection and was revised on 2012 (approx).The patient was implanted with an antibiotic spacer and approx 3-5 months later the patient was implanted.Early this year the patient started to experience pain.On (b)(6) 2021 the patient followed up with his surgeon where an x-ray was taken and was told that his implant was cracked.The surgeon recommended revision.Patient would like some assistance with medical bills and revision surgery.Patient is seeking compensation.This pi is for revision of primary due to infection.
Additional Manufacturer Narrative
Reported event: an event regarding infection involving a triathlon insert was reported.The event was confirmed via medical review.Method & results: -product evaluation and results: not performed as the device was not returned.-clinician review: a review of the provided medical information by a clinical consultant indicated: [.] conclusion of assessment: this inquiry reports a total knee implant that initially failed due to infection.Another inquiry reports another failure of the reimplanted revision implant due to loosening and tibial stem fracture.[.] i can confirm that both events took place since i was able to review the x-rays and photographs and operation notes.Regarding the possible root cause of these events, infection can be caused by contamination at the time of original surgery, wound healing problems, or possibly by hematogenous spread from a distal focus.[.] -product history review: review of the device history records indicate 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 lot or sterile lot referenced.Conclusion: it was reported that the patient was revised due to infection.The event was confirmed through review of the provided medical records by a clinical consultant.All stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.The exact cause of the event could not be determined from the information provided.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported by patient's wife, patient had a right tka on 2010 (approx).Within a year of the surgery patient started to experience pain and swelling.The patient followed up with his surgeon and was told he had an infection and was revised on 2012 (approx).The patient was implanted with an antibiotic spacer and approx 3-5 months later the patient was implanted.Early this year the patient started to experience pain.On (b)(6), 2021 the patient followed up with his surgeon where an x-ray was taken and was told that his implant was cracked.The surgeon recommended revision.Patient would like some assistance with medical bills and revision surgery.Patient is seeking compensation.This pi is for revision of primary due to infection.

• Brand Name: NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12413548
• Report Number: 0002249697-2021-01491
• Device Sequence Number: 11920721
• Product Code: MBH
• UDI-Device Identifier: 07613327027297
• UDI-Public: 07613327027297
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/04/2022

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: 11/30/2012
• Device Model Number: 5537-G-511
• Device Catalogue Number: 5537-G-511
• Device Lot Number: 013MPD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 10/21/2021; 02/18/2022; 04/11/2022
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 11/15/2021; 03/13/2022; 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 77 KG