MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5532-G-409-E

Device Problems Device Damaged Prior to Use (2284); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2023

Event Type  malfunction  

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.H3 other text : device not returned to the manufacturer.

Event Description

When the iud was removed from the packaging during implantation, it had a loose locking wire.The surgeon had to take another implant, this one was not implanted.

Manufacturer Narrative

Reported event: an event regarding disassociation involving a triathlon insert was reported.The event was confirmed via the provided photograph of the device.Method & results: -product evaluation and results: the reported device was not returned; however, a photograph was provided for review.The photograph shows the insert in a plastic bag with labels.The labels partially obscure the view of the insert but it appears that the locking wire has completely disassociated from the poly insert.Nothing further can be observed from the photograph.-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 locking wire came loose from the triathlon insert during surgery.The reported device was not returned; however, a photograph was provided for review.The photograph shows the insert in a plastic bag with labels.The labels partially obscure the view of the insert but it appears that the locking wire has completely disassociated from the poly insert.Nothing further can be observed from the photograph.Further information such as return of the device is needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If device(s) and/or additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

When the iud was removed from the packaging during implantation, it had a loose locking wire.The surgeon had to take another implant, this one was not implanted.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• Type of Device: 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: 17983375
• MDR Text Key: 326233740
• Report Number: 0002249697-2023-01238
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327338355
• UDI-Public: 07613327338355
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K172634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5532-G-409-E
• Device Lot Number: L91A6L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other