MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #6 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5510-F-601
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "left total knee.Revision was secondary to patella dislocation.There was no mention of mako being relevant to the patella dislocation.No further information available from the surgeon or hospital." spoke to rep.Patellar dislocation was addressed by re-suturing the capsule.While in the knee, surgeon decided to exchange a 6x9 cs insert for another 6x9 cs insert.There were no allegations against the revised insert.
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, 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 reported discrepancies.There have been no other events for the lot referenced.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving a triathlon femoral component was reported.The event was not confirmed.Method & results: -device evaluation and results: visual inspection, material analysis, functional and dimensional inspections could not be performed as the device remained implanted.-clinician review: no medical records were received for review with a clinical consultant.- device 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.Conclusion: it was reported that the patient required surgery to address dislocation of the patella.The event could not be confirmed because insufficient information was provided.Further information such as return of the device, pre- and post-operative x-rays, revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.The patient is also enquiring whether their implants are part of a recall.A search indicated that the reported device is not part of a recall.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
As reported: "left total knee.Revision was secondary to patella dislocation.There was no mention of mako being relevant to the patella dislocation.No further information available from the surgeon or hospital." spoke to rep.Patellar dislocation was addressed by re-suturing the capsule.While in the knee, surgeon decided to exchange a 6x9 cs insert for another 6x9 cs insert.There were no allegations against the revised insert.Update: as reported via medwatch mw5147161: as reported via medwatch mw5147162: after having a total knee replacement in 2022 the kneecap released and had to have revision surgery and now my kneecap has moved again resulting in another revision surgery.The surgeon has rescheduled another total knee replacement again to be done on (b)(6) 2023.Is this because of a defective knee replacement? the brand of knee replacement was stryker, i've heard of stryker having recalls on their products.

• Brand Name: TRIATHLON CR FEM COMP #6 L-CEM
• 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-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16542069
• Report Number: 0002249697-2023-00263
• Device Sequence Number: 6265044
• Product Code: MBH
• UDI-Device Identifier: 07613327040319
• UDI-Public: 07613327040319
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

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 Model Number: 5510-F-601
• Device Catalogue Number: 5510F601
• Device Lot Number: PSR4H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2023
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2022
• 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: 71 YR
• Patient Sex: Male