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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 01/01/2019

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.Device was used for treatment, not diagnosis.(b)(4).

Event Description

Literature article entitled "total hip arthroplasty for hip fractures: 5-year follow-up of functional outcomes in the oldest independent old and very old patients", by daniel godoy monzo'n, md, et.Al, published in geriatric orthopaedic surgery & rehabilitation 2014, vol.5 (1) 3-8, reviewed by clinician for mdr reportability.This study aimed to determine the dislocation and reoperation rate, functional outcomes, and the survival rate of the unique subset of very old but lucid and independent patients with hip fractures following a total hip arthroplasty (tha) and geriatric team-coordinated perioperative care.Of these 93 patients, garden classifications for their fractures were: 61 type iii (65.5%) and 32 type iv (34.5%).Surgery was performed using a posterolateral approach, releasing and then reattaching the short rotators and conserving the piriformis.The patients received a cemented c-stem with ogee cup, both from depuy orthopaedics.The femoral head was 28 mm and the acetabular component was an all-polyethylene cup with a long posterior wall.The following complications occurred: within the first month after each patient's primary operation, 3 patients expired for unidentified reasons.Within the span of five years following primary implantation, a total of thirty patients (including the first three within the first month), of the total 93 patients, expired for unreported causes.In no cases was it suggested that the implanted depuy products or the primary procedure caused or contributed to the reported patient deaths.This complaint addresses 33 instances of this product to capture the 33 reported deaths of unknown cause.

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.Additional 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.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8332841
• MDR Text Key: 135955205
• Report Number: 1818910-2019-84273
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/12/2019
• Supplement Dates Manufacturer Received: 03/15/2019
• Supplement Dates FDA Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death