MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON MB PATELLA PA A32; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5554L320

Device Problem Material Deformation (2976)

Patient Problems Pain (1994); Injury (2348)

Event Date 12/03/2018

Event Type  Injury  

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 other similar events for the lot referenced.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.Not returned.

Event Description

As reported: "patient complained of pain and clicking in knee.All available information submitted".Explant picture provided by the rep shows a metalback patella with its poly portion exhibiting notable damage.An a32 metalback patella and 3x9 insert were revised to an a32 x3 patella and 3x11 cr insert.

Event Description

As reported: "patient complained of pain and clicking in knee.All available information submitted".Explant picture provided by the rep shows a metalback patella with its poly portion exhibiting notable damage.An a32 metalback patella and 3x9 insert were revised to an a32 x3 patella and 3x11 cr insert.

Manufacturer Narrative

An event regarding pain and audible noise involving a triathlon patella was reported.An explant photograph of the device confirmed damage to the device however pain and audible noise could not be confirmed.Method & results product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs note the following: one explant photo was provided.It shows the metal back of the patella having come away from the poly piece and it also shows that the poly is significantly damaged.Biological material is also present on the device.Medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: cannot confirm event, need revision operative report and clinical past medical history.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: 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 and revision 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 devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON MB PATELLA PA A32
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8204590
• MDR Text Key: 131701750
• Report Number: 0002249697-2018-04181
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327049893
• UDI-Public: 07613327049893
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: 5554L320
• Device Lot Number: SY4KY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 88