MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN BONE SCREWS

Catalog Number UNK_REC

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 11/11/2015

Event Type  Injury  

Manufacturer Narrative

An event regarding disassociation involving an adm liner and ceramic head was reported.A review by a clinical consultant confirmed a fracture of a bone screw.Method & results: device evaluation and results: a visual, functional and dimensional inspection was not performed as the device was not returned.Medical records received and evaluation: a review of the medical records by a clinical consultant noted the presence of a gap cup with broken screws and extensive bone graft on x-ray indicates this prior surgery was clearly a revision surgery for otherwise unknown problems.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of device, operative reports, additional 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.

Event Description

Sales rep informed that revision surgery was operated due the dislocation of hip.Item ref 6570-0-028 delta v-40 ceramic head 28/-4 had come out from the restoration adm x3 ins 28/48 1236-2-848.Surgeon (b)(6) removed both items and implemented new ones.

• Brand Name: UNKNOWN BONE SCREWS
• Type of Device: UNKNOWN BONE SCREW
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5405071
• MDR Text Key: 37334361
• Report Number: 0002249697-2016-00268
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2016
• 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: 70 YR
• Patient Weight: 98