MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 3; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5521-B-300
Medical Device Problem Codes	Fracture (1260); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Inflammation (1932); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646)
Date of Event	10/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
As reported: "patient is a (b)(6) female who previously underwent right total knee replacement - outside cors scope (roi in 2016).She underwent revision for tibial component loosening (b)(6) 2017, all components revised.Patient required a second revision due to aseptic loosening of femoral component performed in (b)(6) 2020.All components where exchanged." an op report was provided which cited aseptic loosening of the tibia, and "around the femur, there was also extensive amount of bone loss and the femur appeared to be also loose.We therefore decided to remove both components.".
Additional Manufacturer Narrative
Reported event: an event regarding loosening and crack/fracture involving a triathlon baseplate was reported.The event was confirmed only for loosening based on medical records 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 records by a clinical consultant stated the following comment: 10/27/2020: stryker pi report.On 06/06/2017: operative note.¿op note revision #1¿.Suspected aseptic loosening of tibia.Leukocyte esterase negative.Tibia grossly loose.Femoral component fixed.But removed so as to use semi constrained implant.Cemented with vanco added.Used #2 femur, #3 tibia and 50mm stems.Poly 3x16mm ps (x-ray shows a ts poly).On 10/27/2020: operative note.¿op note revision #2¿.Aseptic loosening right knee s/p 2 prior operations.Fluid sent for cx.Low cell count.Histology chronic inflammation.Tibia grossly loose.Significant bone loss around femur.Appeared loose.All removed.Cement mantle removed with burr.Small opening in cortex of tibia.Reamed.Mcl and lcl intact.Prepared with augments.Rinsed with providone-iodine and added vanco powder.Stable trialing.Final implants #2 tibia, #2 femur, 5 mm semi augment med tibia, cone d on tibia, bilobed augment on femur, 1 and 2 right, stem 14x100 both and a 19mm poly.Undated: preop x-rays right knee.Varus djd with some patellar subluxation undated: ¿pre-revision #1¿ right knee.Cemented implant with lucency and likely change in position of tibia lift off lateral.Bilateral knees present.Undated: ¿pre-revision #2¿ x-rays right knee.Complete failure of the tibial component now in marked varus.Some lucency on lateral femur.(note ts polyethylene) undated: ¿revision #2¿ x-rays.Long stem cemented triathlon revision.Cement extravasation from tibia likely posterolateral defect as well as likely fracture at posterior tibial cone.Confirmation: a failed primary cemented knee, revision of said knee and subsequent failure of the revision and a second revision surgery may be confirmed from the operative notes and x-rays provided.Root cause: the root cause of what appeared to be aseptic loosening and failure of a primary and revision knee cannot be ascertained without evaluating additional medical records and perhaps the explants.Product 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 lot referenced.Conclusions: it was reported that patient was revised due to aseptic loosening of the tibia, and "around the femur, there was also extensive amount of bone loss and the femur appeared to be also loose.The event was confirmed for only loosening based on medical records.A review of the provided medical records by a clinical consultant stated the following comment: 10/27/2020: stryker pi report.On (b)(6) 2017: operative note.¿op note revision #1¿.Suspected aseptic loosening of tibia.Leukocyte esterase negative.Tibia grossly loose.Femoral component fixed.But removed so as to use semi constrained implant.Cemented with vanco added.Used #2 femur, #3 tibia and 50mm stems.Poly 3x16mm ps (x-ray shows a ts poly).On (b)(6) 2020: operative note.¿op note revision #2¿.Aseptic loosening right knee s/p 2 prior operations.Fluid sent for cx.Low cell count.Histology chronic inflammation.Tibia grossly loose.Significant bone loss around femur.Appeared loose.All removed.Cement mantle removed with burr.Small opening in cortex of tibia.Reamed.Mcl and lcl intact.Prepared with augments.Rinsed with providone-iodine and added vanco powder.Stable trialing.Final implants #2 tibia, #2 femur, 5 mm semi augment med tibia, cone d on tibia, bilobed augment on femur, 1 and 2 right, stem 14x100 both and a 19mm poly.Undated: preop x-rays right knee.Varus djd with some patellar subluxation undated: ¿pre-revision #1¿ right knee.Cemented implant with lucency and likely change in position of tibia lift off lateral.Bilateral knees present.Undated: ¿pre-revision #2¿ x-rays right knee.Complete failure of the tibial component now in marked varus.Some lucency on lateral femur.(note ts polyethylene) undated: ¿revision #2¿ x-rays.Long stem cemented triathlon revision.Cement extravasation from tibia likely posterolateral defect as well as likely fracture at posterior tibial cone.Confirmation: a failed primary cemented knee, revision of said knee and subsequent failure of the revision and a second revision surgery may be confirmed from the operative notes and x-rays provided.Root cause: the root cause of what appeared to be aseptic loosening and failure of a primary and revision knee cannot be ascertained without evaluating additional medical records and perhaps the explants.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device are needed to complete the investigation for determining root cause.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
As reported: "patient is a 57-year-old female who previously underwent right total knee replacement - outside cors scope (roi in 2016).She underwent revision for tibial component loosening (b)(6) 2017, all components revised.Patient required a second revision due to aseptic loosening of femoral component performed in (b)(6) 2020.All components where exchanged." an op report was provided which cited aseptic loosening of the tibia, and "around the femur, there was also extensive amount of bone loss and the femur appeared to be also loose.We therefore decided to remove both components.".

• Brand Name: TRI TS BASEPLATE SIZE 3
• 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: 12334634
• Report Number: 0002249697-2021-01410
• Device Sequence Number: 3001876
• Product Code: MBH
• UDI-Device Identifier: 07613327026313
• UDI-Public: 07613327026313
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2021

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: 05/31/2022
• Device Model Number: 5521-B-300
• Device Catalogue Number: 5521-B-300
• Device Lot Number: AHZ9EA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 09/13/2021
• 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: 91