MAUDE Adverse Event Report: STRYER ORTHOPAEDICS. HIP IMPLANTS; PROSTHESIS, HIP

Lot Number MJN91L

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Test Result (2695)

Event Date 08/01/2018

Event Type  Injury  

Event Description

Woke up and left hip was in terrible pain and could hardly walk.(b)(6) 2018, had x-ray of hip.Orthopedic dr said he saw fluid and deterioration and figured it was a stryker recall hip.Had mri following week and blood work.Showed cobalt level too high 6.5.Hips were put in (b)(6) 2011 and (b)(6) 2012.We were never informed of the hip recall, was a complete surprise on (b)(6) when i had the x-ray.

• Brand Name: HIP IMPLANTS
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): STRYER ORTHOPAEDICS.
• MDR Report Key: 7805668
• MDR Text Key: 118049465
• Report Number: MW5079306
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/19/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: MJN91L
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 83 YR
• Patient Weight: 82