MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 23MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-023; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6276-1-023

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Injury (2348); No Information (3190)

Event Date 12/04/2015

Event Type  Injury  

Manufacturer Narrative

No further information will be made available due to hospital and surgeon policy.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported that surgeon was going to wash out hip and upon opening patient, the surgeon went to take an x-ray as surgeon thought he noticed the screw was sitting proud.X-ray was negative and surgeon then went into joint and disengaged body and put in a new screw and body and completed case.Infection was not confirmed.

Manufacturer Narrative

An event regarding infection and seating/locking issues involving a restoration modular bolt was reported.The event was not confirmed.Method and results: device evaluation and results: not performed as the device was not performed.Medical records received and evaluation: not performed as medical records were not provided.Device history review: device history review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: a review of the complaint history database shows that there have been no similar reported events for the reported lot.Conclusions: the exact cause of the event could not be determined based on the information provided.Further information such as return of device, operative reports, x-rays, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.Product surveillance will continue to monitor for trend no further investigation is possible at this time.If the device and/or additional information becomes available, this investigation will be reopened.

Event Description

It was reported that surgeon was going to wash out hip and upon opening patient, the surgeon went to take an x-ray as surgeon thought he noticed the screw was sitting proud.X-ray was negative and surgeon then went into joint and disengaged body and put in a new screw and body and completed case.Infection was not confirmed.

• Brand Name: 23MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-023
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5315822
• MDR Text Key: 34035657
• Report Number: 0002249697-2015-04416
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121308
• 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: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2010
• Device Catalogue Number: 6276-1-023
• Device Lot Number: 52695001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2015
• 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