MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT - US ONLY; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number TR7100-R

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 04/09/2012

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.

Event Description

It was reported by the patient's attorney as a result of a legal claim that allegedly patient underwent bilateral tkas on (b)(6) 2012 with shapematch cutting guides and the use of the guides led to these implants failing prematurely, requiring revision.It is further alleged that within 18 months, she was in more pain than prior to her surgeries, sought a second opinion and will undergo a right knee revision once the contralateral side has healed, likely in early 2016.

Manufacturer Narrative

An event regarding alleged pain involving a us shapematch cutting guide was reported.The event was not confirmed.Medical records received and evaluation: insufficient medical records were received for review with a clinical consultant.Device history review: confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: review of the event description indicates that the patient experienced alleged pain after the primary total hip arthroplasty ((b)(6) 2012).However, the exact cause of the reported pain could not be determined because the devices were not returned for evaluation and insufficient medical information was provided.

Event Description

It was reported by the patient's attorney as a result of a legal claim that allegedly patient underwent bilateral tkas on (b)(6) 2012 with shapematch cutting guides and the use of the guides led to these implants failing prematurely, requiring revision.It is further alleged that within 18 months, she was in more pain than prior to her surgeries, sought a second opinion and will undergo a right knee revision once the contralateral side has healed, likely in early 2016.

• Brand Name: PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT - US ONLY
• 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-MAHWAH; 325 corporate drive; suite 200; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5230887
• MDR Text Key: 31436481
• Report Number: 0002249697-2015-03798
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TR7100-R
• Device Lot Number: 12066045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/21/2015
• Initial Date FDA Received: 11/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2249697-11/19/12-013-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR