MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #5 R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5510-F-502
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	03/16/2021
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.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 pain.Pre-operatively, the surgeon suspected the cause of pain to be femoral loosening and osteolysis due to poly wear, due to lucency seen on x-ray.Intra-operatively, though noted to not be grossly loose, the existence or degree of looseness of the cemented femoral component was not reported to the rep.The poly had no visible wear.Rep is requesting investigation results on the insert, which is allegedly being reconfirmed returned.Patient was revised to a size 4 ps femur with a 5x10 insert.Rep that no further information will be released by the hospital or surgeon.
Event or Problem Description
It was reported that the patient's right knee was revised due to pain.Pre-operatively, the surgeon suspected the cause of pain to be femoral loosening and osteolysis due to poly wear, due to lucency seen on x-ray.Intra-operatively, though noted to not be grossly loose, the existence or degree of looseness of the cemented femoral component was not reported to the rep.The poly had no visible wear.Rep is requesting investigation results on the insert, which is allegedly being returned.Patient was revised to a size 4 ps femur with a 5x10 insert.Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Correction: d9/h3 product not returned for this item.Reported event an event regarding loosening involving a triathlon femoral component 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: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate the 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: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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.H3 other text : device not returned.

• Brand Name: TRIATHLON CR FEM COMP #5 R-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
• MDR Report Key: 11642743
• Report Number: 0002249697-2021-00656
• Device Sequence Number: 3160494
• Product Code: MBH
• UDI-Device Identifier: 07613327040302
• UDI-Public: 07613327040302
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2021

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: 09/30/2024
• Device Model Number: 5510-F-502
• Device Catalogue Number: 5510F502
• Device Lot Number: JAX2R
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/24/2021
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 07/29/2021
• 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