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 Loose or Intermittent Connection (1371); Mechanical Problem (1384); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); Joint Dislocation (2374); No Code Available (3191)

Event Date 07/13/2015

Event Type  Injury  

Event Description

It was reported by stryker sales rep that a revision of cone conical took place on (b)(6) to see the cause of a patient dislocation.It was further reported that "on opening it was found the cone body to be retroverted.When attempting removal the screw was loose and body disengaged easily.Surgeon understands that this may be down to his own error but would like the implants investigated to check screw in / taper mechanism just in case and to allow for extra information for the patient.".

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

An event regarding dislocation as a result of seating/locking and involving a restoration modular body and a restoration modular stem.The event was confirmed from the medical review which also indicated cup malposition was a contributory factor.Method & results: device evaluation and results: visual inspection: there was evidence of bony on-growth on the returned body.The device was dimensionally inspected and found compliant.Functional testing was performed and the components assembled together and the body did not rotate on the stem.Medical records received and evaluation: a review of the records by a clinical consultant note: ''the core problem of this case was recurrent dislocation of the revision arthroplasty with three closed reductions documented.When such dislocations become recurrent, an indication for revision surgery is present, three dislocations are about the threshold for new surgery.During the second revision, there was retroversion of the rmcc stem with a rather loose connection between stem and proximal body as suggested by the rather loose locking bolt.'' ''such a stem retroversion is clearly a relevant factor to contribute to recurrent dislocation, however there is another issue in the arthroplasty to contribute to the same problem and such is the rather low to absent cup anteversion''.''though the balance between the two contributing factors of cup malposition and inadequate tightening of the locking bolt will never be accurately known, they both quite likely have contributed to the problem of recurrent dislocation in the rmcc system''.Diagnosis: cup malposition in low to absent anteversion together with inadequate tightening of the restoration modular locking bolt between body and stem have contributed to retroversion of the rmcc device causing recurrent dislocation and thereby requiring a new revision surgery.Device history review: device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: a review of the complaint history database shows that there have been no similar reported events for the subject lot code.Conclusions: a review by a clinical consultant noted: though the balance between the two contributing factors of cup malposition and inadequate tightening of the locking bolt will never be accurately known, they both quite likely have contributed to the problem of recurrent dislocation in the rmcc system.Diagnosis: cup malposition in low to absent anteversion together with inadequate tightening of the restoration modular locking bolt between body and stem have contributed to retroversion of the rmcc device causing recurrent dislocation and thereby requiring a new revision surgery no further investigation is possible and there were no manufacturing issues noted with the returned device.If additional information becomes available, this investigation will be reopened.

Event Description

It was reported by stryker sales rep that a revision of cone conical took place on (b)(6) to see the cause of a patient dislocation.It was furher reported that "on opening it was found the cone body to be retroverted.When attempting removal the screw was loose and body disengaged easily.Surgeon understands that this may be down to his own error but would like the implants investigated to check screw in / taper mechanism just in case and to allow for extra information for the patient.".

• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4974548
• MDR Text Key: 6077202
• Report Number: 0002249697-2015-02586
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 6276-1-023
• Device Lot Number: 45062301
• Other Device ID Number: STER. LOT 1310GCM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2013
• 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