MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALAMEDA DESIGNED ITEM PRIOR TO SYK PURCHASE; INSTRUMENT

Catalog Number TR3100-R-OAL

Device Problems Incorrect Measurement (1383); Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Injury (2348); Ambulation Difficulties (2544)

Event Date 06/15/2009

Event Type  Injury  

Event Description

It was reported that: the patient had severe pain, instability, cutting guides were incorrectly measured and the cuts were wrong.Patient states that the custom cutting guides used to be called otis med and are now called shape match tech.Patient had revision surgery on (b)(6) 2012.

Manufacturer Narrative

Additional information indicated that this device is "alameda designed item prior to syk purchase" and it was used during primary surgery on (b)(6) 2008 prior to acquisition of alameda by stryker.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available, the evaluation summary will be submitted in a supplemental report.

Manufacturer Narrative

A review of the provided medical records by a clinical consultant indicated: ¿the pi as submitted does not appear to be related to the use of shape match cutting guides or the triathlon implant.While this case was within the scope of product recall regulatory action 2012-171, this pi was not felt to be related to the shapematch cutting jigs.Instability experienced by the patient was felt related to ligament insufficiency.¿ a clinician consultant has reviewed the provided information and has indicated that "the pi as submitted does not appear to be related to the use of shape match cutting guides or the triathlon implant.Instability experienced by the patient was felt related to ligament insufficiency.¿ there is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.If additional information becomes available, this investigation will be reopened.

Event Description

It was reported that: the patient had severe pain, instability, cutting guides were incorrectly measured and the cuts were wrong.Patient states that the custom cutting guides used to be called otis med and are now called shape match tech.Patient had revision surgery on (b)(6) 2012.

• Brand Name: ALAMEDA DESIGNED ITEM PRIOR TO SYK PURCHASE
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-ALAMEDA; 1600 harbor bay parkway; suite 200; alameda CA 94502
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3948942
• MDR Text Key: 4643432
• Report Number: 0002249697-2014-02809
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/15/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TR3100-R-OAL
• Device Lot Number: LIP128-B4574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 64 YR