MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT ARC/HA COLLAR STEM#8; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number S-2337-HF08

Device Problems Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395); Unintended Movement (3026)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 08/17/2016

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested and if received, will be provided in the supplemental report.Not returned to manufacturer.

Event Description

Patient's hip was revised due to a loose femoral stem and dislocating total hip.

Manufacturer Narrative

An event regarding subsidence involving a securfit stem was reported.The event was confirmed.Method and results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.-medical records received and evaluation: based on provided medical records were reviewed by a consulting clinician who indicated: "the provided medical records were reviewed by a consulting clinician who indicated: on (b)(6)2016 a revision of the left hip stem was performed for a diagnosis of ¿recurrent dislocation left tha secondary to subsidence of femoral stem¿.The operative report describes general anesthesia and the previous scar was opened.The operative report notes, ¿previous acetabulum well-aligned and retained ¿ stem had subsided and anteverted ¿ extracted with little effort.¿ it was changed to a restoration modular and the labels indicate an 18/155 stem with a 23/plus-10 v-40 body and a 36/0 v-40 lfit head were utilized.Uncomplicated surgery was described.No x-rays and no examination of the explanted components are available.The stem subsidence in the post-operative femoral fracture was not related to factors of faulty total hip component design, manufacturing or materials." -device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there has been no other event for the lot referenced.Conclusions: the event was confirmed by the consulting clinician in the medical review who indicated: "the provided medical records were reviewed by a consulting clinician who indicated: on (b)(6) 2016 a revision of the left hip stem was performed for a diagnosis of ¿recurrent dislocation left tha secondary to subsidence of femoral stem¿.The operative report describes general anesthesia and the previous scar was opened.The operative report notes, ¿previous acetabulum well-aligned and retained ¿ stem had subsided and anteverted ¿ extracted with little effort.¿ it was changed to a restoration modular and the labels indicate an 18/155 stem with a 23/plus-10 v-40 body and a 36/0 v-40 lfit head were utilized.Uncomplicated surgery was described.No x-rays and no examination of the explanted components are available.The stem subsidence in the post-operative femoral fracture was not related to factors of faulty total hip component design, manufacturing or materials." the root cause could not be determined because the devices were not returned for evaluation.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Patient's hip was revised due to a loose femoral stem and dislocating total hip.

• Brand Name: SECUR-FIT ARC/HA COLLAR STEM#8
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5953793
• MDR Text Key: 54876512
• Report Number: 0002249697-2016-02954
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K941366
• 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: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: S-2337-HF08
• Device Lot Number: 5X67HE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2016
• 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: 88 YR