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

Catalog Number UNK_REC

Device Problem Insufficient Information (3190)

Patient Problem Hematoma (1884)

Event Date 03/10/2016

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report.

Event Description

It was reported that patient had a right thr approximately 6 weeks prior.Patient was brought back for subcutaneous hematoma and the doctor performed an exploratory arthrotomy.The doctor irrigated and debrided the joint, removed the femoral head and liner and replaced with a new femoral head with sleeve and polyethylene liner.

• Brand Name: UNKNOWN LINER
• 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: 5545581
• MDR Text Key: 41795990
• Report Number: 0002249697-2016-01065
• Device Sequence Number: 1
• Product Code: JDG
• 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: 03/10/2016

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: 03/10/2016
• Initial Date FDA Received: 04/04/2016
• 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): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 123