MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN STEM; HIP IMPLANT

Catalog Number UNK_REC

Device Problems Mechanical Problem (1384); Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problems Injury (2348); Joint Dislocation (2374); No Information (3190)

Event Date 09/08/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported by sales rep that suspected 36 mm head dissociation from stem.Surgeon showed him an x-ray that showed head dissociated from stem.

Manufacturer Narrative

Additional information: returned to manufacturer on: no an event regarding disassociation involving an unknown stem was reported.The event was confirmed.Method & results: -device evaluation and results: not performed as the device was not returned.-medical records received and evaluation: the provided x-ray was reviewed by a consulting clinician who indicated the undated x-ray confirms the disassociation and deformity of the trunnion but need operative reports, clinical and past medical history, need dated x-rays and examination of explanted components to complete the medical assessment.-device history review could not be performed as the device lot is unknown.-complaint history review could not be performed as the device lot is unknown.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as operative reports, clinical and past medical history, dated x-rays and examination of explanted components 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 trends.

Event Description

It was reported by sales rep that suspected 36mm head dissociation from stem.Surgeon showed him an x-ray that showed head dissociated from stem.

• Brand Name: UNKNOWN STEM
• Type of Device: HIP IMPLANT
• 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: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5999616
• MDR Text Key: 56457202
• Report Number: 0002249697-2016-03174
• Device Sequence Number: 1
• Product Code: JDI
• 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,Followup
• Report Date: 01/18/2017

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 Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2016
• Initial Date FDA Received: 10/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/18/2017
• 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): Required Intervention