MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS STRYKER ORTHOPAEDICS; HIP IMPLANT

Lot Number MKM0EE

Device Problem Metal Shedding Debris (1804)

Patient Problem No Code Available (3191)

Event Date 11/11/2011

Event Type  Injury  

Event Description

(b)(6) 2011, this (b)(6) male underwent a total left hip arthroplasty under dr(b)(6) at (b)(6) hosp.A stryker rejuvenate modular neck and stem device was implanted.Pt became symptomatic with his hip and went to see (b)(6)on (b)(6) 2014.(b)(6) 2014, pt underwent revision of left hip and had stryker rejuvenate device explanted by dr (b)(6).Extensive debridement of the joint was done.

• Brand Name: STRYKER ORTHOPAEDICS
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS; 325 corporate dr; mawah NJ 07430
• MDR Report Key: 4321086
• MDR Text Key: 5207303
• Report Number: 4321086
• Device Sequence Number: 1
• Product Code: KWL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2015
• Device Lot Number: MKM0EE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/13/2014
• Distributor Facility Aware Date: 11/12/2014
• Device Age: 3 YR
• Event Location: Ambulatory Surgical Facility
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 47 YR
• Patient Weight: 95