MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN DALL MILES CABLE; HIP IMPLANT

Catalog Number UNK_SHC

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Injury (2348); Joint Dislocation (2374)

Event Date 04/19/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding crack/fracture involving a dall miles cable was reported.The event was confirmed.Method and results: device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical records and/or x-rays by a clinical consultant indicated: the trochanteric non-union is still present with failure of bony healing as evident by the loose pieces of bone on x-ray and the fractured dm-cables and loose dm-plate.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the investigation concluded that the event was caused by non-union of a greater trochanteric fracture, present already before implantation of the predicate devices after a periprosthetic fracture due to a fall of the patient in 2015, despite adequate treatment, has contributed to an overload condition on the implanted constrained liner forcing a complete pull-out of the constrained liner from the cup shell requiring a third revision in april 2018.The trochanteric non-union is still present with failure of bony healing as evident by the loose pieces of bone on x-ray and the fractured dm-cables and loose dm-plate.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

As reported: "chronic dislocations, constrained liner damage during dislocation.[dall miles] plate removed".Left hip.Update 14 june, 2018: the medical review has confirmed that the constrained liner has disassociated from an unknown trident shell.It has also confirmed loosening of the dall miles plate.The conclusion of the assessment is as follows: non-union of a greater trochanteric fracture, present already before implantation of the predicate devices after a periprosthetic fracture due to a fall of the patient in 2015, despite adequate treatment, has contributed to an overload condition on the implanted constrained liner forcing a complete pull-out of the constrained liner from the cup shell requiring a third revision in (b)(6) 2018.Update 18 june 2018: a review by a clinical consultant has confirmed a fractured dall miles cable.This has been added to the product grid.

• Brand Name: UNKNOWN DALL MILES CABLE
• Type of Device: HIP IMPLANT
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7691694
• MDR Text Key: 114103209
• Report Number: 0002249697-2018-02187
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2018
• 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: 87 YR
• Patient Weight: 51