MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #2; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5520-B-200
Medical Device Problem Codes	Loss of Osseointegration (2408); Migration (4003)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646)
Date of Event	09/27/2022
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.Device not returned to the manufacturer.
Event or Problem Description
Primary right triathlon (tka) baseplate found to have subsided following primary surgery.Surgeon removed it, replaced with universal baseplate.Femur unaffected and remained in situ.
Event or Problem Description
Primary right triathlon (tka) baseplate found to have subsided following primary surgery.Surgeon removed it, replaced with universal baseplate.Femur unaffected and remained in situ.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a triathlon baseplate was reported.The event was confirmed via medical review.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photograph shows a recently explanted baseplate.Blood and biological matter was observed on the device.Medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: as described above, a patient underwent a cemented total knee arthroplasty and then approximately four years later required revision for tibial loosening.The patient was significantly obese with a bmi of 43.9.I can confirm that loosening of the primary implant occurred since i was able to review the pre-revision x-ray.I can confirm that revision occurred as i was also able to review the post revision x-ray.I cannot determine the root cause of this event with certainty.The causes of tibial loosening approximately four years after surgery are multifactorial including the original surgical technique regarding positioning and alignment and fixation as well as patient factors including elevated bmi and activity level.I would not assign any causality to the implant itself.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: as described above, a patient underwent a cemented total knee arthroplasty and then approximately four years later required revision for tibial loosening.The patient was significantly obese with a bmi of 43.9.I can confirm that loosening of the primary implant occurred since i was able to review the pre-revision x-ray.I can confirm that revision occurred as i was also able to review the post revision x-ray.I cannot determine the root cause of this event with certainty.The causes of tibial loosening approximately four years after surgery are multifactorial including the original surgical technique regarding positioning and alignment and fixation as well as patient factors including elevated bmi and activity level.I would not assign any causality to the implant itself.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.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #2
• 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: 15630996
• Report Number: 0002249697-2022-01519
• Device Sequence Number: 7941705
• Product Code: MBH
• UDI-Device Identifier: 07613327041569
• UDI-Public: 07613327041569
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K031729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2023

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: 07/31/2022
• Device Model Number: 5520-B-200
• Device Catalogue Number: 5520B200
• Device Lot Number: CTC6Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 100 KG