MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DALL MILES SS 2.0MM CABLE; CERCLAGE, FIXATION

Catalog Number 3704-8-240

Device Problems Break (1069); Fracture (1260); Inadequacy of Device Shape and/or Size (1583); Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Irritation (1941); Pain (1994); Injury (2348); Non-union Bone Fracture (2369); Disability (2371); Joint Disorder (2373)

Event Date 11/11/2002

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Original tha exeter femoral x-change procedure performed following car accident in 2002.Revision of right hip exeter femoral x-change (exeter long stem 44mm #3 200mm) due to cable failure and trochantic plate displacement resulting in non union of greater trochanter and external rotation of leg causing pain and deformity, also noted leg length discrepancy.In this procedure above stem removed noticed: pain, irritation on lateral hip due to broken cables, leg external rotation, leg length shortening.

Manufacturer Narrative

Corrected data: device not returned.An event regarding a fractured dall miles cable was reported.The event was confirmed.Method & results: device evaluation and results: not performed as the reported device was not returned.Medical records received and evaluation: a medical review was performed and concluded: "use of a too small device for fracture fixation purposes in the proximal femur has contributed to failure of fracture fixation and development of trochanteric pseudarthrosis requiring repair with more suitable devices." device history review: a dhr review could not be performed as the lot id is unknown.Complaint history review: a complaint history review could not be performed as the lot id is unknown.Conclusions: a medical review was performed and concluded that "use of a too small device for fracture fixation purposes in the proximal femur has contributed to failure of fracture fixation and development of trochanteric pseudarthrosis requiring repair with more suitable devices." there was no indication of a device related issue on review of the medical review.No further investigation is required at this time.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

Original tha exeter femoral x-change procedure performed following car accident in 2002.Revision of right hip exeter femoral x-change (exeter long stem 44mm #3 200mm) due to cable failure and trochanteric plate displacement resulting in non union of greater trochanter and external rotation of leg causing pain and deformity, also noted leg length discrepancy.In this procedure above stem removed noticed: pain, irritation on lateral hip due to broken cables, leg external rotation, leg length shortening.

• Brand Name: DALL MILES SS 2.0MM CABLE
• Type of Device: CERCLAGE, FIXATION
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6619547
• MDR Text Key: 76908191
• Report Number: 0002249697-2017-01794
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K971741
• 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: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3704-8-240
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 35 YR
• Patient Weight: 90