MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT PS#8 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5532G813

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problems Injury (2348); No Information (3190)

Event Date 05/11/2016

Event Type  Injury  

Manufacturer Narrative

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

Triathlon ps #8 x 13 post was broken.Implanted (b)(6) 2012.

Manufacturer Narrative

An event regarding fractured ps post involving a triathlon ps insert was reported.The event was confirmed.Method & results: -device evaluation and results: material analysis of the device indicated that the post of the x3 triathlon insert ps#8 13mm broke in fatigue with the fracture starting on the posterior surface and progressing in an anterior direction.Damage from contact with the femoral component was observed on the anterior side of the post.Burnishing, scratching and third body indentations were observed on the articulating surfaces of the insert and are commonly identified damage modes on uhmwpe inserts.No material or manufacturing defects were observed during this examination.-medical records received and evaluation: insufficient medical records were provided for review.-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: material analysis of the device indicated that the post of the x3 triathlon insert ps#8 13mm broke in fatigue with the fracture starting on the posterior surface and progressing in an anterior direction.Damage from contact with the femoral component was observed on the anterior side of the post.Burnishing, scratching and third body indentations were observed on the articulating surfaces of the insert and are commonly identified damage modes on uhmwpe inserts.No material or manufacturing defects were observed during this examination.The exact cause of the event could not be determined because insufficient information was provided.Further information such as further 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

Triathlon ps #8x13 post was broken.Implanted (b)(6) 2012.

• Brand Name: X3 TRIATHLON INSERT PS#8 13MM
• 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-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5704647
• MDR Text Key: 46762841
• Report Number: 0002249697-2016-01841
• 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: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2013
• Device Catalogue Number: 5532G813
• Device Lot Number: LBI216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/23/2008
• 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: 71 YR
• Patient Weight: 113