MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE4 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-411
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/24/2021
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.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.
Event or Problem Description
The following was reported: revision due to poly wear.
Event or Problem Description
The following was reported: revision due to poly wear.
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a triathlon insert was reported.The event was confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device confirms that the device was worn/damaged at a posterior edge which is consistent with articulation against hard object.Explantation damage was also observed on the insert.Material analysis: no material non-conformances with the uhmwpe insert were found, nor any manufacturing defects seen on any of the device¿s surfaces.-clinician review: a review of the provided medical information by a clinical consultant indicated: "i have had the opportunity to review documentation.This included the product inquiry summary, an x-ray report in a foreign language, an operative report in a foreign language and an implant record from the index surgery.[¿] from the information provided i am unable to confirm this event or its root cause.If further information becomes available i would be happy to further this assessment." -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: it was reported that the patient was revised due to wear of the polyethylene insert.Visual inspection of the returned device confirms that the device was worn/damaged at a posterior edge which is consistent with articulation against hard object.Explantation damage was also observed on the insert.No material non-conformances with the uhmwpe insert were found, nor any manufacturing defects seen on any of the device¿s surfaces.A review of the provided medical information by a clinical consultant was unable to determine root cause due to insufficient information provided.It was reported that the patient was "very active" post-implantation, so this may have contributed to the device failure.This would need to be supported by further patient history information.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.

• Brand Name: X3 TRIATHLON CS INS SIZE4 11MM
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12441490
• Report Number: 0002249697-2021-01518
• Device Sequence Number: 3655290
• Product Code: MBH
• UDI-Device Identifier: 07613327045789
• UDI-Public: 07613327045789
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2022

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: 08/31/2019
• Device Model Number: 5531-G-411
• Device Catalogue Number: 5531G411
• Device Lot Number: LDY617
• 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: 08/16/2021
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2014
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 72 KG