MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP IMPLANT

Catalog Number UNK HIP

Device Problem Fracture (1260)

Patient Problems Pain (1994); Tissue Damage (2104); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 06/21/2016

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.This report is for an unknown device/unknown lot.Part and lot number are unknown; udi number is unknown.(b)(4).

Event Description

Maude report received.Hip replacement surgery with depuy mom pinnacle right on above date.Continued pain, difficulty walking with clicking, squealing, popping, heavy metal screening of the blood done in 2012.Abnormally high levels of cobalt and chromium.Revision surgery done in 2012 with removal of the ball with replacement of ceramic.The socket was lined with heavy duty plastic and left in place.Muscle damage surrounding the prosthetic which caused weakness and continued pain.Sudden pain developed in 2016.Mri showed fractured screws in the socket and rubbing it on the pelvis.One broken off screw still in pelvis.Continued chronic pain, gait disturbance and inability to walk up stairs and do other movements due to the muscle damage which could lead to an increased risk of a hip dislocation.Doi: (b)(6) 2005 - dor: (b)(6) 2016 (right hip) (cup and 3 screws).

Manufacturer Narrative

Product complaint # (b)(4).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 number was not provided.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.

• Brand Name: UNKNOWN HIP IMPLANT
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-XXXX ; 6107428552
• MDR Report Key: 8486560
• MDR Text Key: 141026599
• Report Number: 1818910-2019-89863
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/05/2019
• Supplement Dates Manufacturer Received: 04/17/2019
• Supplement Dates FDA Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention