MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #5 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-509
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Urinary Retention (2119)
Date of Event	01/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient, he had a right tka done on (b)(6), 2020.Patient has been experiencing pain since his surgery.He has problems urinating, unable to lay down and has to sleep on a recliner and he's experiencing popping.His pain has never stopped.
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.Device not returned.
Additional Manufacturer Narrative
Reported event: an event regarding pain involving a triathlon insert was reported.The event was confirmed via clinician review of the provided medical records.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a review of the provided medical records by a clinical consultant indicated: the event description from the product inquiry summary states: it was reported by the patient, he had a right tka done on (b)(6) 2020.Patient has been experiencing pain since his surgery.He has problems urinating, unable to lay down and has to sleep on a recliner and he's experiencing popping.His pain has never stopped.It is confirmed that the patient had a cemented primary total knee performed on (b)(6) 2020 and had ongoing global knee pain post-operatively.Workup for this nonspecific pain ruled out infection and no mechanical cause was determined.At his first post-operative office visit at two weeks post surgery it was noted that the patient was experiencing urinary retention and had to have a catheter placed.He was awaiting a urology consultation.The root cause for the ongoing pain following tka cannot be determined from this limited documentation.Both x-rays and an mri show a cemented tka in anatomic position without evidence of mechanical complication.Synovial fluid analysis and culture reports showed no evidence of infection.Post operative urinary retention is a well recognized possible complication of surgery.Should additional information become available i would be happy to further this review.-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.Conclusion: it was reported that the patient is experiencing pain post implantation of stryker knee components.A review of the provided medical records by a clinical consultant indicated: the event description from the product inquiry summary states: it was reported by the patient, he had a right tka done on (b)(6) 2020.Patient has been experiencing pain since his surgery.He has problems urinating, unable to lay down and has to sleep on a recliner and he's experiencing popping.His pain has never stopped.It is confirmed that the patient had a cemented primary total knee performed on (b)(6) 2020 and had ongoing global knee pain post-operatively.Workup for this nonspecific pain ruled out infection and no mechanical cause was determined.At his first post-operative office visit at two weeks post surgery it was noted that the patient was experiencing urinary retention and had to have a catheter placed.He was awaiting a urology consultation.The root cause for the ongoing pain following tka cannot be determined from this limited documentation.Both x-rays and an mri show a cemented tka in anatomic position without evidence of mechanical complication.Synovial fluid analysis and culture reports showed no evidence of infection.Post operative urinary retention is a well recognized possible complication of surgery.Should additional information become available i would be happy to further this review.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported by the patient, he had a right tka done on (b)(6) 2020.Patient has been experiencing pain since his surgery.He has problems urinating, unable to lay down and has to sleep on a recliner and he's experiencing popping.His pain has never stopped.

• Brand Name: X3 TRIATHLON CS INSERT #5 9MM
• 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: 14257963
• Report Number: 0002249697-2022-00632
• Device Sequence Number: 5283202
• Product Code: MBH
• UDI-Device Identifier: 07613327045871
• UDI-Public: 07613327045871
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2022

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: 09/30/2024
• Device Model Number: 5531-G-509
• Device Catalogue Number: 5531G509
• Device Lot Number: LJL150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 07/04/2022
• Initial Report FDA Received Date: 05/02/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2019
• 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: Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 108 KG