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

Model Number	5532-G-509
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Joint Laxity (4526)
Date of Event	12/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: a recall inquiry was requested on a triathlon insert.The patient is asymptomatic.Clinician review of provided medical records revealed and confirmed instability and rom issues.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: adverse event identified: patient complaint of pain and clicking and some apparent instability.Patient query as to potential of an implant recall.Hazards: none clearly related to implant.Conclusion of assessment: the patient appeared unhappy with her outcome and had ongoing pain, clicking and some instability requiring her to hang on to something.She wondered if her implants had been recalled.Based on the lot numbers no recall was found associated with her implants.The complaints appeared unrelated to the implants themselves.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: her medical records indicated that on (b)(6) 2020, on the left the rom was 0-90°, also with 1mm opening to varus stress and stable to valgus stress.There was a mild infusion and good strength.Clinician review revealed none clearly related to implant.The exact cause of the event could not be determined.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.It was reported that the customer was inquiring if the reported device is subject to a recall.Based on the review, none of these reported products have been involved in a recall.
Event or Problem Description
Patient would like to know if her implant are part of a recall.Patient is asymptomatic.Updated on 01apr2021 based on medical review: "until (b)(6) 2020 on the left the rom was 0-90°, also with 1mm opening to varus stress and stable to valgus stress.There was a mild infusion and good strength.".

• Brand Name: TRIATHLON PS 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: 11724092
• Report Number: 0002249697-2021-00731
• Device Sequence Number: 3137889
• Product Code: MBH
• UDI-Device Identifier: 07613327050776
• UDI-Public: 07613327050776
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2021

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: 08/31/2023
• Device Model Number: 5532-G-509
• Device Catalogue Number: 5532-G-509
• Device Lot Number: 91637218C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 04/26/2021
• 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: Other
• Patient Age: 62 YR
• Patient Weight: 100