MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI LM/RL TIB AUG SZ4 5MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5545-A-401
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Inflammation (1932); Pain (1994); Ambulation or Postural Difficulties (2544); Fibrosis (3167)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding loosening, periprosthetic fracture, and arthrofibrosis involving a triathlon augment 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.Clinician review: a review of the provided medical information by a clinical consultant indicated: conclusion of assessment: this inquiry reports another failure of the reimplanted revision implant due to loosening and tibial stem fracture.I can confirm that this event took place since i was able to review the x-rays and photographs and operation notes.The root cause of loosening is multifactorial.The surgeon elected to use a hybrid cement/cementless technique which in my experience has not been successful.I would also be concerned that it was decided to go ahead with reimplantation, despite a frozen section that showed acute inflammation.I would have re-debrided and inserted another spacer.The loosening can be due to recurrent infection and the hybrid technique.Regarding fracture of the tibial stem, causes are multifactorial including surgical technique, infection, implant factors and patient factors.Given the single postoperative revision xray i would have concern about the longevity of the construct due to the varus positioning and radiolucencies.The root cause of arthrofibrosis is multifactorial including surgical technique factors and patient factors.The root cause of a tibial plateau fracture is also multifactorial including trauma, and patient factors.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 referenced.Conclusions: the events were confirmed through review of the provided medical records by a clinical consultant.The exact cause of the events could not be determined because insufficient information was provided.Additional information including return of the device, operative notes from the implantation surgery, and pathology reports are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Not available.
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 (b)(6) and revision surgery.Patient is seeking compensation.This pi is for pain and crack/fracture after revision.Update: "new surgery that happened (b)(6) 2021, to replace the cracked prosthetic." update (b)(6) 2022: review of medical files indicated loosening of both tibial and femoral components.
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 pain and crack/fracture after revision.Update: "new surgery that happened (b)(6) to replace the cracked prosthetic." update 03/feb/2022: review of medical files indicated loosening of both tibial and femoral components.Update 17/feb/2022: tibial plateau fracture and arthrofibrosis were identified intra-operatively during the revision procedure.Update 11-april-2022: femoral components were indicated to be "well-positioned, well-fixed" in revision op report, and they were not explanted.
Additional Manufacturer Narrative
Reported event: an event regarding loosening, periprosthetic fracture, and arthrofibrosis involving a triathlon augment 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.Clinician review: a review of the provided medical information by a clinical consultant indicated: conclusion of assessment: [this] inquiry reports another failure of the reimplanted revision implant due to loosening and tibial stem fracture arthrofibrosis and tibial plateau fracture.I can confirm that [these] events took place since i was able to review the x-rays and photographs and operation notes.The root cause of loosening is multifactorial, including surgical technique factors and patient factors.Regarding fracture of the tibial stem, causes are also multifactorial including surgical technique factors, patient factors, and implant factors.The root cause of arthrofibrosis is multifactorial including surgical technique factors and patient factors.The root cause of a tibial plateau fracture is also multifactorial including surgical technique factors, trauma, and patient factors.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 referenced.Conclusions: the events were confirmed through review of the provided medical records by a clinical consultant.The exact cause of the events could not be determined from the information provided.No further investigation for this event is possible at this time.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: TRI LM/RL TIB AUG SZ4 5MM
• 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: 13563853
• Report Number: 0002249697-2022-00248
• Device Sequence Number: 19325119
• Product Code: MBH
• UDI-Device Identifier: 07613327026153
• UDI-Public: 07613327026153
• 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: 2012
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2022

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: 11/30/2016
• Device Model Number: 5545-A-401
• Device Catalogue Number: 5545-A-401
• Device Lot Number: FPZEA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2011
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 77 KG