MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

Device Problem Corroded (1131)

Patient Problems Pain (1994); Scar Tissue (2060); Tissue Damage (2104); Weakness (2145); Cramp(s) (2193); Distress (2329); Injury (2348); Test Result (2695)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This information was reported by a non-healthcare professional.Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

On 1/18/2019 litigation was received.Patient communication received.As stated, "i had mom tha on 2009 of the right hip and mom tha on 2010 of the left hip.On 2010, i experienced significant pain while weight bearing in my left leg/hip.An ultrasound and blood tests were completed in 2011.An effusion was noted on the ultrasound of the left hip.Cramping has occurred in the right thigh since 2009/2010, blood work has been conducted at least annually to track co and cr levels.Mri's were conducted in 2016 and 2018 and an effusion was detected in 2018, on the mri of the right hip, co levels are in the high risk range and cr levels are in the upper moderate risk range.Current symptoms include pain when lying on the right side and decreased strength in the right hip.Bilateral hip revision surgery is scheduled for 2019." this complaint is for the right hip.Patient indicates she is currently experiencing pain, effusion, soft tissue issues, cramping, elevated ions, and that her implants are giving off debris.She is scheduled for a bilateral revision surgery in 2019.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 8323829
• MDR Text Key: 135680778
• Report Number: 1818910-2019-83853
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2018

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 HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2019
• Initial Date FDA Received: 02/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1