MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 5 TRIATH TS PLUS TIB INS X3 POLY 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5537-G-511-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	02/06/2023
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 similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The following devices were also listed in this report: device name#tri ts femur sz6 left ; cat#5512-f-601 ; lot#ih39d.Device name#tri ts baseplate size 5 ; cat#5521-b-500 ; lot#htx3ra.Device name#triathlon asymmetric x3 patella ; cat#5551-g-381-e ; lot#52tx.Device name#triathlon sym cone aug sz e ; cat#5549-a-150 ; lot#gtg61.Device name#triathlon cemented stem-15mm x 50mm ; cat#5560-s-115 ; lot#1119777k.Device name#triathlon cemented stem-15mm x 50mm ; cat#5560-s-115 ; lot#1109673h.Device name#tri distal augment sz6 10mm ; cat#5541-a-600 ; lot#ixt9v.Device name#triathlon fem dist aug 10mm size 6 right ; cat#5541-a-602 ; lot#isx9z.Device name#unknown_lim_product ; cat#unk_lim ; lot#unknown.Device name#unknown_lim_product ; cat#unk_lim ; 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
It was reported that an mua was performed on the patient's left knee on 6-feb-2023.Pre-mua rom 5-85 degrees; post mua 0-125 degrees.
Additional Manufacturer Narrative
An event regarding range of motion (rom) 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: a review of provided medical records with a clinical consultant indicated: "conclusion/assessment: very little medical history particularly preoperative evaluation was provided.Little postop care was provided for review.No preoperative x-rays provided for review.The patient who apparently had undergone multiple surgeries prior to a total knee presented with difficulty with motion and very poor range of motion of about 15 to 80 degrees.Infection workup and or other preoperative workup were not provided for review.Revision knee arthroplasty was proposed.The procedure was performed without complication.A tibial cone and femoral augments were used.Short cemented stems were used.The patient did fine postoperatively and was discharged postop day 1.Physical therapy records and postoperative management were not provided for review.The patient presented for 6-week postop with poor progression.Motion was not documented.The plan was for manipulation under anesthesia.The manipulation was performed (b)(6) 2023 (1 month later).Intraoperatively range of motion improved significantly.The results of the manipulation were not documented as there is no further follow-up care provided for review.Event confirmation: a revision knee arthroplasty can be confirmed, a manipulation under anesthesia thereafter can be confirmed.Root cause: the root cause for the revision arthroplasty appeared to be stiffness, no other reasons were given for the procedure.The root cause for the manipulation under anesthesia after the revision was poor progress and poor range of motion.The root cause for the poor motion cannot be determined at this time." device 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 was revised due to limited range of motion.A review of provided medical records with a clinical consultant indicated: "event confirmation: a revision knee arthroplasty can be confirmed, a manipulation under anesthesia thereafter can be confirmed.Root cause: the root cause for the revision arthroplasty appeared to be stiffness, no other reasons were given for the procedure.The root cause for the manipulation under anesthesia after the revision was poor progress and poor range of motion.The root cause for the poor motion cannot be determined at this time." the exact cause of the event could not be determined because insufficient information was provided.Further information such as 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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that an mua was performed on the patient's left knee on (b)(6) 2023.Pre-mua rom 5-85 degrees; post mua 0-125 degrees.

• Brand Name: NO 5 TRIATH TS PLUS TIB INS X3 POLY 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arunabha mukherjee ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19459180
• Report Number: 0002249697-2024-00835
• Device Sequence Number: 6812781
• Product Code: MBH
• UDI-Device Identifier: 07613327288315
• UDI-Public: 07613327288315
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2024

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 Catalogue Number: 5537-G-511-E
• Device Lot Number: WT5X37
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2022
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 117 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White