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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Cyst(s) (1800); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Tissue Damage (2104); No Code Available (3191)

Event Date 01/09/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Occupation: attorney.

Event Description

Clinical report states that patient was revised to address heterotopic ossification and an adverse reaction to metal debris.Update ad 22 feb 2019: in addition to what were previously alleged, litigation alleges pain, suffering and mental anguish.As per litigation record, surgeon discovered corrosion of the femoral trunnion, gray metal debris and staining, osteolysis of the acetabulum, fluid-filled cyst, pseudotumorous masses, and necrosis in capsule was attributable to metal shedding debris.These findings were consistent with a diagnosis of metallosis, aseptic lymphocyte dominated vasculitis associated lesion and adverse reaction to metal debris.Doi: (b)(6) 2006; dor: (b)(6) 2017; right hip.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: h6 (patient and device).H6 patient code: no code available (3191) was used to capture absence of treatment.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.Device history lot: null.Device history batch : null.Device history review: null.

Manufacturer Narrative

Product complaint (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added; a2(dob), b5, h6(patient).No code available use absence of treatment.

Event Description

Ppf alleged infection.Added date of birth of patient and updated patient harm.Doi: (b)(6) 2006 dor: (b)(6) 2017 right hip.

• 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: 8424351
• MDR Text Key: 138906745
• Report Number: 1818910-2019-87376
• 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: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 103