MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT PS#2 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5532G216

Device Problems Difficult to Insert (1316); Loose or Intermittent Connection (1371); Mechanical Problem (1384); Positioning Problem (3009)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/29/2015

Event Type  malfunction  

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

It was reported that surgeon was finishing a right total knee and when the surgeon opened the tibial insert, he noticed that the metal piece/bar on the insert was loose and falling off.Surgeon had rep open a new insert and surgeon implanted the new insert accordingly.

Manufacturer Narrative

An event regarding a seating/locking issue involving a triathlon insert was reported.The event was confirmed.Method & results: -device evaluation and results: the insert was returned without the locking wire therefore it is not possible to confirm that the locking wire was loose and falling off.Visual inspection of the returned component did indicate that the types of damage observed on the insert are indicative of an attempt to assemble the insert with a baseplate component.-medical records received and evaluation: not performed as no medical records were provided.-device history review: indicated devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: review of the reported lot confirms no other similar events reported.Conclusions: based on the visual inspection of the returned component, it appears that an attempt was made to assemble the insert with a baseplate component.No further investigation for this event is required at this time.

Event Description

It was reported that surgeon was finishing a right total knee and when the surgeon opened the tibial insert, he noticed that the metal piece/bar on the insert was loose and falling off.Surgeon had rep open a new insert and surgeon implanted the new insert accordingly.

• Brand Name: X3 TRIATHLON INSERT PS#2 16MM
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5182286
• MDR Text Key: 30030473
• Report Number: 0002249697-2015-03468
• 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: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 5532G216
• Device Lot Number: LCH409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2015
• Initial Date FDA Received: 10/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2011
• 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
• Patient Age: 65 YR