MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 40MM METAL FEMORAL HEAD; HIP IMPLANT

Catalog Number UNK_REC

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem Injury (2348)

Event Date 10/31/2016

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Per sales rep, metal femoral head dissociated from the stem.The trunnion of implanted stem was damaged.Both stem and head had to come out.

Manufacturer Narrative

An event regarding disassociation involving an unknown metal head was reported.The event was confirmed.-medical records received and evaluation: the provided medical information was submitted to a consulting clinician who indicated that undated x-ray confirms disassociation but deemed the information insufficient and rejected it for a medical review, further information such as operative reports, clinical and past medical history, dated x-rays and examination of explanted components are needed to complete the medical assessment.Conclusions: as per provided medical information consulting clinician indicated that undated x-ray confirms disassociation however, 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.

Event Description

Per sales rep, metal femoral head dissociated from the stem.The trunnion of implanted stem was damaged.Both stem and head had to come out.

• Brand Name: UNKNOWN 40MM METAL FEMORAL HEAD
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6118670
• MDR Text Key: 60621544
• Report Number: 0002249697-2016-03752
• 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: 01/24/2017

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: 10/31/2016
• Initial Date FDA Received: 11/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/24/2017
• 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: 64 YR