MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 7 TRIATH TS PLUS TIB INS X3 POLY 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5537-G-709-E
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Discomfort (2330); Ambulation or Postural Difficulties (2544)
Date of Event	01/30/2024
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.
Event or Problem Description
It was reported that the patient's right knee was revised.Approximately 2 weeks after implantation, patient complained knee 'didn't feel right.' the insert was found to have dissociated from the baseplate.Nothing unusual had been noted upon implantation, no fall or trauma was reported.The implant was replaced into the existing baseplate and had no issues locking in.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a triathlon insert was reported.The event was confirmed via clinician review of the provided medical records.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device is damaged in the area of the locking mechanism.The locking wire has disassociated.Damage is consistent with disassociation and/or explantation.Clinician review: a review of the provided medical records by a clinical consultant indicated: "postoperative radiographs with staples in place.Long stem cemented triathlon.Good alignment and position.On the ap the locking wire is clearly not engaged with the baseplate.It looks like the post is not engaged as well.On the lateral the locking post is not in the tibia and the poly appears anteriorly displaced and dislocated from the tibial tray.[¿] event confirmation: the event can be confirmed, disengagement of a ts poly from the tibial tray.Root cause: the root cause of the loss of fixation of the polyethylene cannot be determined without additional information.That said, an immediate postoperative x-ray would be helpful to determine if the polyethylene was ever locked into the tray and if the locking post had been fully seated.".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 was revised due to disassociation of the insert from the baseplate.Visual inspection of the returned device indicated that the device is damaged in the area of the locking mechanism.The locking wire has disassociated.Damage is consistent with disassociation and/or explantation.A review of the provided medical records by a clinical consultant indicated: "postoperative radiographs with staples in place.Long stem cemented triathlon.Good alignment and position.On the ap the locking wire is clearly not engaged with the baseplate.It looks like the post is not engaged as well.On the lateral the locking post is not in the tibia and the poly appears anteriorly displaced and dislocated from the tibial tray.Event confirmation: the event can be confirmed, disengagement of a ts poly from the tibial tray.Root cause: the root cause of the loss of fixation of the polyethylene cannot be determined without additional information.That said, an immediate postoperative x-ray would be helpful to determine if the polyethylene was ever locked into the tray and if the locking post had been fully seated." 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 the patient's right knee was revised.Approximately 2 weeks after implantation, patient complained knee 'didn't feel right.' the insert was found to have dissociated from the baseplate.Nothing unusual had been noted upon implantation, no fall or trauma was reported.The implant was replaced into the existing baseplate and had no issues locking in.

• Brand Name: NO 7 TRIATH TS PLUS TIB INS X3 POLY 9MM
• 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: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18772503
• Report Number: 0002249697-2024-00284
• Device Sequence Number: 17274681
• Product Code: MBH
• UDI-Device Identifier: 07613327287851
• UDI-Public: 07613327287851
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

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-709-E
• Device Lot Number: 8W5XLN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2023
• 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: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male