MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED

Catalog Number 5520-B-400

Device Problem Osseointegration Problem (3003)

Patient Problems Pain (1994); Inadequate Osseointegration (2646)

Event Date 11/14/2016

Event Type  Injury  

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.

Event Description

This pi is for the left knee.Patient's wife called stating her husband had bilateral knee replacements and reported pain and loosening.

Event Description

This pi is for the left knee.Patient's wife called stating her husband had bilateral knee replacements and reported pain and loosening.Patient would like to know if the implants and the shapematch cutting guide were involved in a recall update 10-july-2019: impression noted for left knee "radiographic findings are indicative of loosening of the tibial prosthesis.Certainly, an infection is in the differential diagnosis."patient notified that he is scheduled to have a left knee revision on (b)(6) 2019.

Manufacturer Narrative

The following devices were also listed in this report: unknown joint replacement_product; cat# unk jr; lot# unknown.Triathlon cr fem comp #5 l-cem; cat# 5510f501; lot# a9s4b.Triathlon asymmetric x3 patella; cat# 5551-g-299; lot# 6kkn.X3 triathlon cs ins size4 16mm; cat# 5531g416; lot# lek465.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An event regarding loosening and subsidence involving a triathlon baseplate was reported.The event was confirmed by medical review.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: review of these records confirm subsidence and loosening of the tibial component in a cemented left tka.The root cause for the loss of component fixation can not be established however the tibial component is undersized which may have been a contributing factor." product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: medical review concluded the following: review of these records confirm subsidence and loosening of the tibial component in a cemented left tka.The root cause for the loss of component fixation can not be established however the tibial component is undersized which may have been a contributing factor.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.

• Brand Name: TRIATHLON PRIM TIB BASEPLATE - CEMENTED
• Type of Device: TRIATHLON PRIM TIB BASEPLATE - CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8666256
• MDR Text Key: 146912490
• Report Number: 0002249697-2019-02152
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 5520-B-400
• Device Lot Number: WVLAB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 109