MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT MAX 127 HIP STEM #12; IMPLANT

Catalog Number 6052-1240S

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

Patient Problems Pain (1994); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 08/18/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information was requested and if it becomes available will be submitted in a supplemental report.Patient elected to keep.

Event Description

Patient's hip was revised for femoral pain and leg length deficiency.Femoral stem was replaced with rest mod stem and mdm head.

Manufacturer Narrative

An event regarding limb length discrepancy involving a securfit stem was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as no device was returned for investigation.-medical records received and evaluation: not performed as no patient medical records were provided for review.-device history review: all devices accepted into final stock conformed to specification.-complaint history review: there have been no similar previous reported events for this lot id.Conclusions: the exact cause of the event could not be determined because no patient medical records were provided for review and the device was not returned for investigation.No further investigation for this event is possible at this time.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Patient's hip was revised for femoral pain and leg length deficiency.Femoral stem was replaced with rest mod stem and mdm head.

• Brand Name: SECUR-FIT MAX 127 HIP STEM #12
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5077097
• MDR Text Key: 25774488
• Report Number: 0002249697-2015-03007
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051738
• 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: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 6052-1240S
• Device Lot Number: MND0HW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2014
• 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: 79 YR