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-309-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994); Swelling/ Edema (4577)
Date of Event	10/28/2022
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.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.Catalog numbers and lot codes of other devices listed in this report: 5515-f-402 triathlon ps fem component, cemented lot euv3hd.5521-b-300 tri ts baseplate size 3 lot e3h3ta.5550-g-298-e triathlon symmetric x3 patella lot 11p9.5575x000 triathlon fix.Peg 2 per pk lot jt42r.6197-9-001 simplex p with tobramycin 1 pack x 2 lot mhb021.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.
Event or Problem Description
Patient left voicemail on patient hotline reporting a primary implant on (b)(6) 2020 with triathlon components.Patient reported "multiple problems since" and would like to know if implants are subject to a recall.Update: per conversation with patient: patient reports pain and swelling and noted femoral nerve damage during primary surgery.
Additional Manufacturer Narrative
Reported event: an event regarding pain 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 remains implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: conclusion of assessment: patient with significant complaints after tka including pain, femoral nerve palsy and apparent pain syndrome.An infection work-up was started but the results not provided.Device or procedure related adverse event: none root cause and confirmation: the root cause of the patient¿s complaints cannot be determined from the materials provided.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 is experiencing multiple problems since post-implantation.A review of the provided medical notes concluded: conclusion of assessment: patient with significant complaints after tka including pain, femoral nerve palsy and apparent pain syndrome.An infection work-up was started but the results not provided.Device or procedure related adverse event: none root cause and confirmation: the root cause of the patient¿s complaints cannot be determined from the materials provided.The patient is also inquiring if the reported device is subject to a product recall.Based on the catalog and lot numbers provided, the reported device is not subject to recall.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
Patient left voicemail on patient hotline reporting a primary implant on (b)(6) 2020 with triathlon components.Patient reported "multiple problems since" and would like to know if implants are subject to a recall.Update: per conversation with patient: patient reports pain and swelling and noted femoral nerve damage during primary surgery.Update per medical records received: patient has undergone multiple treatments including manipulation under anesthesia, aspiration, nerve blocks and genicular radiofrequency ablation.Update 17-jan-2023: per patient's email response: "i am going to go ahead and schedule a consult on my knee as it is getting more painful everyday and the swelling is enormous, my knee is now doubled in size since i first contacted you.".

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 15825840
• Report Number: 0002249697-2022-01670
• Device Sequence Number: 6109167
• Product Code: MBH
• UDI-Device Identifier: 07613327337945
• UDI-Public: 07613327337945
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• 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): 02/06/2023

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 Expiration Date: 11/30/2024
• Device Model Number: 5532-G-309-E
• Device Catalogue Number: 5532-G-309-E
• Device Lot Number: XM82W2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 73 KG