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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Degraded (1153)

Patient Problems Pain (1994); Local Reaction (2035); Joint Disorder (2373); Blood Loss (2597); Test Result (2695); No Code Available (3191)

Event Date 03/11/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Complaint description: patient was revised to address pain.Update ad 24 dec 2019: (b)(4) has been reopened under (b)(4) due to the receipt of pinnacle claim submission form and medical record.After review of medical record, patient was revised to address failed right total hip arthroplasty revision with metal on metal total hip replacement with elevated metal ions.Revision notes stated that there was particulate debris.There was some synovial proliferation.Femoral head was removed and there was noted to be some corrosive changes of the trunnion.There was some bleeding below the acetabulum.Also took down some anterior impingement bone.Added stem due to elevated metal ions.Doi: (b)(6) 2008; dor: (b)(6) 2015 (right hip).

Manufacturer Narrative

Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• 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
• MDR Report Key: 9580402
• MDR Text Key: 185613304
• Report Number: 1818910-2020-01552
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/11/2015

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 FEMORAL STEM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/24/2019
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: 08/04/2020
• Supplement Dates FDA Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 126