MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM PATELLA-ASYMMETRIC; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5552-L-320
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Joint Laxity (4526)
Date of Event	02/05/2024
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
It was reported that the patient's right knee was revised due to global instability and pain.Intra-operatively, the following were observed: the locking wire of the insert broke, and the insert dislodged from the baseplate.The femoral component was articulating posteriorly, causing insert wear and metallosis due to articulating with the baseplate.The baseplate's posterior medial portion was broken off.Patient's activity level was normal, no trauma reported.The patient's cr knee (including patellar component) was converted to a ts knee.Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
An event regarding revision involving a triathlon patella 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 stated the following comment: "i can confirm that the patient had the primary total knee arthroplasty and what would appear to be disruption of the locking mechanism of the tibial insert with metal on metal contact, since i was able to see x-rays with the implant in place.I cannot definitely confirm a fracture of the base plate nor can i confirm the revision since i have no supporting documentation such as office notes, operation note, or post revision x-rays.I cannot confirm the intraoperative findings since i have no documentation such as the operational report or intraoperative photographs.Root cause analysis: the root cause of this event cannot be determined with certainty.In this particular case the tibial component appears to be in extreme flexion which could contribute to abnormal wear and could subsequently lead to metal on metal with metallosis and subsequent tibial baseplate fracture with anterior dislocation.The causes of these events are multifactorial including surgical technique, especially in the position of the tibial baseplate, patient factors such as activity level and bmi.I would not necessarily assign causality to the implant itself without further information about what contributed to the so-called global instability.If the implant was left somewhat unstable than global instability could ensue." 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: it was reported that the patient was revised due to instability and pain.Intra-operatively, the following were observed: the locking wire of the insert broke, and the insert dislodged from the baseplate.The femoral component was articulating posteriorly, causing insert wear and metallosis due to articulating with the baseplate.The baseplate's posterior medial portion was broken off.A review of the provided medical records by a clinical consultant stated the following comment: "i can confirm that the patient had the primary total knee arthroplasty and what would appear to be disruption of the locking mechanism of the tibial insert with metal on metal contact, since i was able to see x-rays with the implant in place.I cannot definitely confirm a fracture of the base plate nor can i confirm the revision since i have no supporting documentation such as office notes, operation note, or post revision x-rays.I cannot confirm the intraoperative findings since i have no documentation such as the operational report or intraoperative photographs.Root cause analysis: the root cause of this event cannot be determined with certainty.In this particular case the tibial component appears to be in extreme flexion which could contribute to abnormal wear and could subsequently lead to metal on metal with metallosis and subsequent tibial baseplate fracture with anterior dislocation.The causes of these events are multifactorial including surgical technique, especially in the position of the tibial baseplate, patient factors such as activity level and bmi.I would not necessarily assign causality to the implant itself without further information about what contributed to the so-called global instability.If the implant was left somewhat unstable than global instability could ensue." 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 that the patient's right knee was revised due to global instability and pain.Intra-operatively, the following were observed: the locking wire of the insert broke, and the insert dislodged from the baseplate.The femoral component was articulating posteriorly, causing insert wear and metallosis due to articulating with the baseplate.The baseplate's posterior medial portion was broken off.Patient's activity level was normal, no trauma reported.The patient's cr knee (including patellar component) was converted to a ts knee.Rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: TRITANIUM PATELLA-ASYMMETRIC
• 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-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: arunabha mukherjee ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18814722
• Report Number: 0002249697-2024-00320
• Device Sequence Number: 18275642
• Product Code: MBH
• UDI-Device Identifier: 07613327013542
• UDI-Public: 07613327013542
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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: 10/31/2021
• Device Catalogue Number: 5552-L-320
• Device Lot Number: AN4N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2016
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 96 KG