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 Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/14/2022
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.Device not returned.
Event or Problem Description
Patient reported pain in knee.Surgeon decided to perform a resurfacing of the primary patella due to the progression of the disease.The poly insert was exchanged when surgeon was performing a resurfacing of primary patella.The surgeon performed exchange as a best practice to reduce infection risk.When poly insert was removed, it was noticed that there was a notch/imperfection on the rim of the poly insert.It is not clear if this was caused by impaction or by friction.Update 31 october 2022: the patient had a primary knee replacement some time ago, the patella was not deemed diseased enough to resurface at that point so was left.Then after time the patient complained of pain and it was determined the patella had now become affected by osteoarthritis and needed resurfacing.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon insert was reported.The event was confirmed.Method & results: product evaluation and results: visual inspection of the returned device confirms that the device was damaged at a posterior edge which is consistent with articulation against hard object.The retaining wire has fractured off.Explantation damage observed on the insert.Clinician review: no medical records were received for review with a clinical consultant.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: visual inspection of the returned device confirms that the device was damaged at a posterior edge which is consistent with articulation against hard object.The retaining wire has fractured off.Explantation damage observed on the insert.No further investigation for this event is possible.If additional information become available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.
Event or Problem Description
Patient reported pain in knee.Surgeon decided to perform a resurfacing of the primary patella due to the progression of the disease.The poly insert was exchanged when surgeon was performing a resurfacing of primary patella.The surgeon performed exchange as a best practice to reduce infection risk.When poly insert was removed, it was noticed that there was a notch/imperfection on the rim of the poly insert.It is not clear if this was caused by impaction or by friction.Update (b)(6) 2022: the patient had a primary knee replacement some time ago, the patella was not deemed diseased enough to resurface at that point so was left.Then after time the patient complained of pain and it was determined the patella had now become affected by osteoarthritis and needed resurfacing.

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 15742502
• Report Number: 0002249697-2022-01585
• Device Sequence Number: 14915620
• Product Code: MBH
• UDI-Device Identifier: 07613327382617
• UDI-Public: 07613327382617
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2023

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 Model Number: 5530-G-509-E
• Device Catalogue Number: 5530-G-509-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female