MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #5 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-516
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	01/28/2021
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.Device not returned.
Event or Problem Description
This pi is for the revision of the patient's right knee on (b)(6) 2021.In providing usage sheets while reporting a revision of the patient's right knee on (b)(6) 2021, rep provided a primary usage sheet and a usage sheet from a revision on (b)(6) 2021.A 5x16 cs insert was revised to another 5x16 cs insert due to flexion instability.The reporting rep was not present for the procedure and no records exist confirming any stryker rep was present for the procedure.Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Updated - patient age at time of event.Reported event: an event regarding instability involving a triathlon insert was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: no medical records were received for review with a clinical consultant.-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's knee was revised due to flexion instability.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report 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.
Event or Problem Description
This pi is for the revision of the patient's right knee on (b)(6) 2021.In providing usage sheets while reporting a revision of the patient's right knee on (b)(6) 2021, rep provided a primary usage sheet and a usage sheet from a revision on (b)(6) 2021.A 5x16 cs insert was revised to another 5x16 cs insert due to flexion instability.The reporting rep was not present for the procedure and no records exist confirming any stryker rep was present for the procedure.Rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: X3 TRIATHLON CS INSERT #5 16MM
• 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: 13240094
• Report Number: 0002249697-2022-00072
• Device Sequence Number: 17285391
• Product Code: MBH
• UDI-Device Identifier: 07613327045895
• UDI-Public: 07613327045895
• 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: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2022

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: 11/30/2022
• Device Model Number: 5531-G-516
• Device Catalogue Number: 5531G516
• Device Lot Number: LHE208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2017
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 129 KG