MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ORTHOMAP® VERSATILE HIP 2.0 SOFTWARE; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Catalog Number 6007-616-000

Device Problem Imprecision (1307)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 12/19/2017

Event Type  Injury  

Event Description

It was alleged by the user facility to the sales representative that during a versatile hip navigation procedure, the surgeon did not want to intentionally lengthen the patients leg.After securing final implants, a post operative x ray showed the leg was lengthened by 10mm.The surgeon had to perform a revision surgery on (b)(6) 2017 to correct the length.There was no further medical intervention reported, or surgical delays due to the revision.

Manufacturer Narrative

Device evaluation: follow-up report submitted to document device evaluation results.

Event Description

It was alleged by the user facility to the sales representative that during a versatile hip navigation procedure, the surgeon did not want to intentionally lengthen the patients leg.After securing final implants, a post operative x ray showed the leg was lengthened by 10mm.The surgeon had to perform a revision surgery on (b)(6) 2017 to correct the length.There was no further medical intervention reported, or surgical delays due to the revision.

• Brand Name: ORTHOMAP® VERSATILE HIP 2.0 SOFTWARE
• Type of Device: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: zachary baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7189296
• MDR Text Key: 97284672
• Report Number: 0001811755-2018-00054
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141551
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6007-616-000
• Device Lot Number: VERSION 2.0-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention