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

Catalog Number UNK_JR

Device Problems Unstable (1667); Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 10/05/2015

Event Type  Injury  

Manufacturer Narrative

An event regarding instability involving an unknown stryker hip was reported.The event was not confirmed.Method and results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: no medical records were received for review with a clinical consultant.Product history review: not performed as no lot information was provided.Complaint history review: not performed as no lot information was provided.Conclusions: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as device identification and return, pre and post operative x-rays, operative reports as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Not returned to the manufacturer.

Event Description

In reporting a revision of patient's left hip on (b)(6) 2018, rep reported that patient had a prior revision of stryker devices due to instability 2-3 years ago.

• Brand Name: UNKNOWN STRYKER HIP
• Type of Device: UNK 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: 8032367
• MDR Text Key: 125920961
• Report Number: 0002249697-2018-03593
• Device Sequence Number: 1
• Product Code: KWY
• 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: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2018
• 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: 81 YR
• Patient Weight: 72