MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT HA PSL CUP/CLUSTR SHELL 62MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 2051-2062

Device Problems Migration or Expulsion of Device (1395); Loss of Osseointegration (2408)

Patient Problems Pain (1994); Injury (2348); Ambulation Difficulties (2544); Inadequate Osseointegration (2646)

Event Date 07/25/2017

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported that a surgeon performed a revision on a patient's right hip due to pain and limited motion.X-rays on (b)(6) 2017 revealed that the cup had shifted.Rep reported that the procedure was completed successfully with no surgical delays.Date of original implant is unknown.

Manufacturer Narrative

An event regarding revision due to pain, limited motion and malposition of shell involving an securfit shell was reported.The event was not confirmed.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: no medical records or x-rays were made available for evaluation.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: it was reported that surgeon performed a revision on patient's right hip due to pain and limited motion.Further x-ray revealed that the cup had shifted.The event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

It was reported that a surgeon performed a revision on a patient's right hip due to pain and limited motion.X-rays on (b)(6) 2017 revealed that the cup had shifted.Rep reported that the procedure was completed successfully with no surgical delays.Date of original implant is unknown.

• Brand Name: SECUR-FIT HA PSL CUP/CLUSTR SHELL 62MM
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6805857
• MDR Text Key: 83127308
• Report Number: 0002249697-2017-02551
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2002
• Device Catalogue Number: 2051-2062
• Device Lot Number: 25255201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/1997
• 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): Hospitalization; Required Intervention
• Patient Age: 83 YR