MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #3 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-311
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	08/09/2022
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
Patient reported pain, swelling and difficulty walking.Patient would like to know if implants are subject to a recall.Medwatch mw5111379 received.As reported: "received stryker tibial x3 triathlon knee replacement.Fda safety report id# (b)(4)." catalog and lot for a knee insert is provided.The only other information provided: "outcomes attributed to adverse event: disability or permanent damage.Type of event: serious injury.".
Additional Manufacturer Narrative
The following devices were also listed in this report: triathlon asymmetric x3 patella; cat# 5551-g-320-e; lot# me9n; tri ts baseplate size 3; cat# 5521-b-300; lot# unknown; triathlon cr fem comp #4 r-cem; cat# 5510f402; lot# jhs7d; sterile fluted headless 1/8" pin 3.5" long; cat# 7650-2038a; lot# sc29232d5; simplex p with tobramycin 1 pack; cat# 6197-9-001; lot# mjb035.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding pain involving a triathlon insert was reported.The event was not confirmed, method & results: device evaluation and results: material analysis, visual, dimensional and functional inspections were not performed as the device remains implanted.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review documentation related to pi including the product inquiry summary, and a postoperative radiology report, the event description from the product inquiries summary states: patient reported pain, swelling and difficulty walking.Patient would like to know if implants are subject to a recall.Update 24/august/2022 wg: medwatch mw5111379 received.As reported: "received stryker tibial x3 triathlon knee replacement.Fda safety report id# (b)(4)." catalog and lot for a knee insert is provided.The only other information provided: "outcomes attributed toadverse event: disability or permanent damage.Type of event: serious injury." it is confirmed that the patient did have a knee replacement.The radiology report describes a knee replacement in normal alignment without evidence of mechanical complication or loosening.The limited documentation does not provide confirming evidence of a mechanical complication.As such the root cause for this patient complaint cannot be determined.Should additional information become available i would be happy to further this assessment.Device 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: a review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review documentation related to pi including the product inquiry summary, and a postoperative radiology report, the event description from the product inquiries summary states: patient reported pain, swelling and difficulty walking.Patient would like to know if implants are subject to a recall.Update 24/august/2022 wg: medwatch mw5111379 received.As reported: "received stryker tibial x3 triathlon knee replacement.Fda safety report id# (b)(4)." catalog and lot for a knee insert is provided.The only other information provided: "outcomes attributed to adverse event: disability or permanent damage.Type of event: serious injury." it is confirmed that the patient did have a knee replacement.The radiology report describes a knee replacement in normal alignment without evidence of mechanical complication or loosening.The limited documentation does not provide confirming evidence of a mechanical complication.As such the root cause for this patient complaint cannot be determined.Should additional information become available i would be happy to further this assessment.It is noted that the patient is also inquiring if the device are subject to a recall.Based on the catalog and lot code provided the device reported is not subject to product recall.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
Patient reported pain, swelling and difficulty walking.Patient would like to know if implants are subject to a recall.Medwatch mw5111379 received.As reported: "received stryker tibial x3 triathlon knee replacement.Fda safety report id# (b)(4)." catalog and lot for a knee insert is provided.The only other information provided: "outcomes attributed to adverse event: disability or permanent damage.Type of event: serious injury.".

• Brand Name: X3 TRIATHLON CS INSERT #3 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 15337655
• Report Number: 0002249697-2022-01284
• Device Sequence Number: 20442745
• Product Code: MBH
• UDI-Device Identifier: 07613327045734
• UDI-Public: 07613327045734
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2022

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: 07/31/2024
• Device Model Number: 5531-G-311
• Device Catalogue Number: 5531G311
• Device Lot Number: LJH804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2019
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 66 KG