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

Catalog Number UNK_JR

Device Problem Noise, Audible (3273)

Patient Problem Injury (2348)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Not returned / not received.

Event Description

Right tha (original dos (b)(6) 2006).Initial bearing surface (per patient) either mom or coc - bearing surface revised to mdm due to squeaking in 2015.

• Brand Name: UNKNOWN RIGHT HIP
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7844133
• MDR Text Key: 119148358
• Report Number: 0002249697-2018-02769
• Device Sequence Number: 1
• Product Code: MEH
• 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: 09/04/2018

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_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 09/04/2018
• 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