MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5537-G-519
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	05/17/2021
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 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.Catalog numbers and lot codes of other devices listed in this report: 5521-b-500 tri ts baseplate size 5 lot a4s3oa.5565-s-018 tri press-fit stem 18mm x 100mm lot 0062893k.5570-s-040 triathlon total knee system offset adapter 4mm lot 0053904d.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
Patient had a right tka outside cors scope and then was revised in (b)(6) 2017 outside of cors scope.In (b)(6) 2020 the patient is revised again, now entering cors registry.Patient develops pain and requires a second revision on (b)(6) 2021.
Event or Problem Description
Patient had a right tka outside cors scope and then was revised in (b)(6), 2017 outside of cors scope.In (b)(6), 2020 the patient is revised again, now entering cors registry.Patient develops pain and requires a second revision on (b)(6), 2021.26apr22 - update based on medical review dated 16 february 2022.A document titled "op report pt ds may 17, 2021" is provided: it is an operation report dated (b)(6), 2021.The diagnosis preop and postop was failed right total knee revision.A right total knee revision was carried out.They found that the tibial component was internally rotated but all other components were satisfactory.The tibial component was revised with a tibial cone.
Additional Manufacturer Narrative
Reported event: an event regarding subsidence involving a triathlon baseplate was reported.The event was not confirmed.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 indicated: conclusion of assessment: this inquiry reports failure of a right total knee arthroplasty.It was revised once in 2017 for instability and synovitis, another time for internal rotation of the tibial component in 2020 and a third time also for internal rotation of the tibial component in 2021.I can confirm that the revisions took place since i was able to review the x-rays and operation reports.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of instability are multifactorial.Early instability is usually surgical technique related.Late instability can be due to ligament stretching or patient issues such as activity level and size and possibly trauma.Revision for internal rotation is surgical technique in origin.-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: a review of the provided medical records by a clinical consultant indicated: conclusion of assessment: this inquiry reports failure of a right total knee arthroplasty.It was revised once in 2017 for instability and synovitis, another time for internal rotation of the tibial component in 2020 and a third time also for internal rotation of the tibial component in 2021.I can confirm that the revisions took place since i was able to review the x-rays and operation reports.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of instability are multifactorial.Early instability is usually surgical technique related.Late instability can be due to ligament stretching or patient issues such as activity level and size and possibly trauma.Revision for internal rotation is surgical technique in origin.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.Catalog numbers and lot codes of other devices listed in this report: 5537-g-519, no 5.Triathlon ts plus tibial insert x3 poly 19mm, lot m93llr.5565-s-018, tri press-fit stem 18mm x 100mm, lot 0062893k.5570-s-040, triathlon total knee system offset adapter 4mm, lot 0053904d.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: TRI TS BASEPLATE SIZE 5
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 13652115
• Report Number: 0002249697-2022-00308
• Device Sequence Number: 11392708
• Product Code: MBH
• UDI-Device Identifier: 07613327026320
• UDI-Public: 07613327026320
• 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: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2022

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: 10/31/2022
• Device Model Number: 5537-G-519
• Device Catalogue Number: 5521-B-500
• Device Lot Number: A4S3OA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2017
• 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: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White