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

Catalog Number	5521-B-500
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/24/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device evaluated by manufacturer? device not available.
Event or Problem Description
This pi is for the right knee.It was reported through the communication of an attorney that allegedly the patient was revised due to right and left knee postoperative total knee arthroplasty with instability.
Additional Manufacturer Narrative
An event regarding instability involving a triathlon baseplate was reported.The event was confirmed through clinician review of the provided medical records.Method & results: device evaluation and results: not performed as product was not returned, the reported device remains implanted.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: suboptimal reconstruction of bearing height with the thinnest available 9-mm bearing in a knee joint with major varus deformity and associated bone loss has contributed to early instability in a rather similar way in both knee arthroplasties, implanted during a simultaneous bilateral primary arthroplasty.Multiple additional factors have contributed to a suboptimal end result of the arthroplasty including persistent disease related contracture around the knee requiring early arthroscopic lateral release of the pf-joint in both knees while multiple falling incidents as caused by complex medical comorbidity and required medication have further contributed to the knee laxity by traumatic stretching of knee ligaments.One of the falling incidents caused a periprosthetic fracture just above the left knee arthroplasty requiring open reduction and internal fixation further compromising the functional condition of especially the left knee due to the scar tissue normally associated with fracture healing.Finally did the patient¿s obesity contribute to a secondary but minor degree to the overload condition in the joints, all ultimately requiring bilateral knee revision with bearing exchange within 2-years of primary arthroplasty.Device history review: indicated 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 provided.Conclusion: a review of the provided medical records and x-rays by a clinical consultant indicated: suboptimal reconstruction of bearing height with the thinnest available 9-mm bearing in a knee joint with major varus deformity and associated bone loss has contributed to early instability in a rather similar way in both knee arthroplasties, implanted during a simultaneous bilateral primary arthroplasty.Multiple additional factors have contributed to a suboptimal end result of the arthroplasty including persistent disease related contracture around the knee requiring early arthroscopic lateral release of the pf-joint in both knees while multiple falling incidents as caused by complex medical comorbidity and required medication have further contributed to the knee laxity by traumatic stretching of knee ligaments.One of the falling incidents caused a periprosthetic fracture just above the left knee arthroplasty requiring open reduction and internal fixation further compromising the functional condition of especially the left knee due to the scar tissue normally associated with fracture healing.Finally did the patient¿s obesity contribute to a secondary but minor degree to the overload condition in the joints, all ultimately requiring bilateral knee revision with bearing exchange within 2-years of primary arthroplasty.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
This pi is for the right knee.It was reported through the communication of an attorney that allegedly the patient was revised due to right and left knee postoperative total knee arthroplasty with instability.

• 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
• MDR Report Key: 8878772
• Report Number: 0002249697-2019-02784
• Device Sequence Number: 2028787
• Product Code: MBH
• UDI-Device Identifier: 07613327026320
• UDI-Public: 07613327026320
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2019

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: 01/31/2015
• Device Catalogue Number: 5521-B-500
• Device Lot Number: AJSW
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 11/14/2019
• 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; Disability
• Patient Age: 61 YR