MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5520-B-300
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	09/20/2022
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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported by the sales rep that surgeon notified about the tkr revision is needed.Update: reason for revision due to dislocation.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving a triathlon baseplate was reported.The event was confirmed via clinician review of the provided medical records.Method & results: device 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: event description: it was reported by the sales rep that surgeon notified about the tkr.Revision is needed.Anatomical position: left knee.Product(s) involved: triathlon cr femur #3 left cemented, primary tibial baseplate cemented, cs insert x3 #3 x 11mm materials reviewed: undated/unlabelled: ap left knee x-ray, left lateral x-ray relevant clinical history and timelines: x-rays provided showed a lateral tka with an obvious posterior knee dislocation, complete disarticulation of the femur and tibia in the sagittal plane.There may be a quadriceps rupture based on a bony fragment.There is evidence of a mako procedure based on pin holes.It is unclear if the ap film is from the same event as in this plane there is no gross abnormality.No additional history or medical records were not provided.Date of implant: (b)(6) 2022 (explant (b)(6) 2022).Additional medical interventions noted: revision surgery (b)(6) 2022.Are any additional medical interventions involving stryker devices noted in clinical history: no.Conclusion of assessment: a knee dislocation occurred in an elderly patient within 4 1/2 months of the index operation.No other data were provided for review.Device or procedure related adverse event: triathlon cr cemented tka with cs polyethylene.Root cause and confirmation: a root cause cannot be ascertained without additional information.However, a knee dislocation may be confirmed.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: no further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported by the sales rep that surgeon notified about the tkr revision is needed.Update: reason for revision due to dislocation.

• Brand Name: TRIATHLON PRIM TIB BASEPLATE - CEMENTED
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 15622121
• Report Number: 0002249697-2022-01506
• Device Sequence Number: 6499298
• Product Code: MBH
• UDI-Device Identifier: 07613327050318
• UDI-Public: 07613327050318
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

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: 07/31/2026
• Device Model Number: 5520-B-300
• Device Catalogue Number: 5520-B-300
• Device Lot Number: NHE2S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2022
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2021
• 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: 87 YR
• Patient Sex: Female