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-413-E

Device Problems Device Damaged Prior to Use (2284); Device Dislodged or Dislocated (2923)

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

Event Date 04/17/2023

Event Type  malfunction  

Event Description

It was reported: "the customer informed that when at the opening of the implant, it was not in perfect condition to be implanted¿.A picture has been provided and shows the locking wire is not in place.

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, 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 reported discrepancies.There have been no other events for the lot referenced.

Manufacturer Narrative

An event regarding appearance involving a triathlon insert was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device is damaged/deformed in the area of the locking mechanism.In addition, the locking wire appears to be bent and partially disassociated.The device was further reviewed by the global quality & operations (gqo) team who indicated the following: "further investigation conducted was the examination of the complaint part returned back to stryker under a microscope where evidence of a wires presence and it having been fully seated within the locking wire slot was ensured.It was observed that residual scratches stemming from the insertion of the locking wire were present." 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 insert was observed to be not in perfect conditions upon opening the device packaging.Visual inspection of the returned device indicated that the device is damaged/deformed in the area of the locking mechanism.In addition, the locking wire appears to be bent and partially disassociated.The device was further reviewed by the global quality & operations (gqo) team who indicated the following: "further investigation conducted was the examination of the complaint part returned back to stryker under a microscope where evidence of a wires presence and it having been fully seated within the locking wire slot was ensured.It was observed that residual scratches stemming from the insertion of the locking wire were present." the gqo team also performed a review of the dhr and indicated that "the locking wire features were properly inspected and signed off on by trained operator(s)" and that "there were no noted discrepancies or anomalies" in subsequent processing steps.It cannot be confirmed from the information provided that the reported issue resulted from manufacturing.Furthermore, it is possible that the locking wire dislodged during handling or transportation.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 Description

It was reported: "the customer informed that when at the opening of the implant, it was not in perfect condition to be implanted¿.A picture has been provided and shows the locking wire is not in place.

• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16901543
• MDR Text Key: 314901744
• Report Number: 0002249697-2023-00496
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327338560
• UDI-Public: 07613327338560
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5532-G-413-E
• Device Catalogue Number: 5532-G-413-E
• Device Lot Number: Y862NE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2022
• 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