MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #5 11MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	5531-G-511-E
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Fibrosis (3167); Swelling/ Edema (4577)
Date of Event	05/21/2022
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 having a right knee manipulation under anesthesia due to pain and swelling on (b)(6) 2022.
Event or Problem Description
Patient reported having a right knee manipulation under anesthesia due to pain and swelling on may 21, 2022.Update: spoke with patient who stated that he will be seeing his doctor on 14 january 2023 to determine if a revision will be done.Patient states he is "leaning towards having the revision done as he is experiencing back and bilateral hip pain".Update: date of surgery (b)(6) 2022 per operative report.
Additional Manufacturer Narrative
Reported event: an event regarding rom involving an unknown triathlon knee 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 information by a clinical consultant indicated: conclusion/assessment: the patient had a poor knee range of motion postoperatively which led to mua and arthroscopic lysis of adhesions.He remains dissatisfied and is considering a revision surgery.Event confirmation: poor postoperative range of motion, mua and lysis of adhesions via an arthroscope can be confirmed.Root cause: a root cause cannot be determined with the records provided." -product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient underwent medical intervention to address range of motion issues.The event was confirmed through clinician review of the provided medical records.The exact cause of the event could not be determined because insufficient information was provided.Further information such as device-identifying information (catalog number and lot code), pathology reports, pre- and post-operative x-rays 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.
Additional Manufacturer Narrative
Reported event: an event regarding rom 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 information by a clinical consultant indicated: "conclusion/assessment: the patient had a poor knee range of motion postoperatively which led to mua and arthroscopic lysis of adhesions.He remains dissatisfied and is considering a revision surgery.Event confirmation: poor postoperative range of motion, mua and lysis of adhesions via an arthroscope can be confirmed.Root cause: a root cause cannot be determined with the records provided." product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient underwent medical intervention to address range of motion issues.The event was confirmed through clinician review of the provided medical records.The exact cause of the event could not be determined because insufficient information was provided.Further information such as device lot code, pathology reports, pre- and post-operative x-rays 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.Catalog numbers and lot codes of other devices listed in this report: 5517f502 triathlon p/a cr beaded #5r lot unknown, 5536b500 tritanium bplate triathlon s5 lot unknown, 5556-l-360 tritanium patella-symmetric lot unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Patient reported having a right knee manipulation under anesthesia due to pain and swelling on (b)(6), 2022.Update: spoke with patient who stated that he will be seeing his doctor on (b)(6) 2023 to determine if a revision will be done.Patient states he is "leaning towards having the revision done as he is experiencing back and bilateral hip pain".Update: date of surgery (b)(6) 2022 per operative report.

• Brand Name: X3 TRIATHLON CS INSERT #5 11MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 16022596
• Report Number: 0002249697-2022-01872
• Device Sequence Number: 5884123
• Product Code: KRO
• UDI-Device Identifier: 07613327336450
• UDI-Public: 07613327336450
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2023

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: 5531-G-511-E
• Device Catalogue Number: 5531-G-511-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 02/08/2023; 05/05/2023
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 02/27/2023; 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 96 KG