MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5530-G-509-E
Medical Device Problem Code	Naturally Worn (2988)
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 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
Reported event: an event regarding wear involving a triathlon insert was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: examination by material analysis engineer indicated burnishing, scratching and third body indentation were observed on the insert.These are common damage modes of uhmwpe.Explantation damage was also observed on the insert.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.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: it was reported that the pre-operatively, the surgeon suspected the cause of pain to be femoral loosening and osteolysis due to poly wear.It was further reported that the poly (insert) had no visible wear.Examination by material analysis engineer indicated burnishing, scratching and third body indentation were observed on the insert.These are common damage modes of uhmwpe.Explantation damage was also observed on the insert.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.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 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.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• 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: 11644025
• Report Number: 0002249697-2021-00658
• Device Sequence Number: 14243148
• Product Code: MBH
• UDI-Device Identifier: 07613327382617
• UDI-Public: 07613327382617
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• 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: 06/30/2024
• Device Model Number: 5530-G-509-E
• Device Catalogue Number: 5530-G-509-E
• Device Lot Number: 9E56AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• 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