MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT PS#7 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5532G709

Device Problems Break (1069); Fracture (1260); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problems Injury (2348); Joint Dislocation (2374); No Code Available (3191)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was retained by the patient and was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Patient complained to dr.(b)(6) that when he tied his shoes his knee would dislocate.Dr.(b)(6) discovered during knee revision to exchange with a thicker poly liner, that the post on the ps 7, 9 insert had broken.Dr.(b)(6) replaced with a new size 7, 11 ps insert.

Manufacturer Narrative

An event regarding fracture involving a triathlon insert was reported.The event was confirmed by photograph.Method and results: device evaluation and results: the device was not returned however four photographs were provided.The photographs shows the superior surface of a recently explanted insert with a piece of the post broken off.The broken piece is also present in the photograph.There is also evidence of mild pitting and burnishing on the bearing condyle surfaces with some discolouration, which is indicative of absorption of synovial fluid.Posterior edge based loading on one condyle bearing surface is also present.The inferior surface shows impressions of the baseplate and also has some discolouration, again indicative of absorption of synovial fluid.The anterior face shows damage consistent with explantation of an insert.Device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.Complaint history review: complaint history review confirmed that there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Further information such as product return, pre- and post-operative x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient complained to dr.(b)(6) that when he tied his shoes his knee would dislocate.Dr.(b)(6) discovered during knee revision to exchange with a thicker poly liner, that the post on the ps 7, 9 insert had broken.Dr.(b)(46 replaced with a new size 7, 11 ps insert.

• Brand Name: X3 TRIATHLON INSERT PS#7 9MM
• 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-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5461553
• MDR Text Key: 39085383
• Report Number: 0002249697-2016-00587
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2007
• Device Catalogue Number: 5532G709
• Device Lot Number: LB764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2002
• 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): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 127