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

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Arthritis (1723); Fall (1848); Hematoma (1884); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Laceration(s) (1946); Necrosis (1971); Pain (1994); Tissue Damage (2104); No Code Available (3191)

Event Date 08/26/2017

Event Type  Injury  

Manufacturer Narrative

(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).

Event Description

The literature article entitled, "survivorship of a modular acetabular cup system: medium-to long-term follow-up" written by kirk kindsfater, md and jim lesko, phd published by arthroplasty today 4 (2018) 376e382 published online 26 august 2017 was reviewed.The article's purpose was to evaluate the survivorship of the pinnacle acetabular cup system.Data was compiled from 1592 primary thas between july 2000 and june 2007 with follow ups at 6 weeks, 6 months and then annually with a minimum of 5 years and maximum of 10 years.Depuy products utilized: pinnacle cup, stem, liners (metal or poly), head (metal or ceramic).The article states all components were distributed by depuy.Adverse events: revision for reasons of - dislocation, deep infection, altr, fracture of femur, stem loosening, head failure, cup loosening, hematoma, pain (not related to altr); complications listed in table 6 - device dislocation, device failure, device-device incompatibility, medical device site reaction, pain, infection, skin infection, fall , femur fracture, hip fracture, iliotibial band syndrome, incision site complication, joint dislocation, laceration, muscle strain, pelvic fracture, skeletal injury, soft tissue injury, stress fracture, arthralgia, arthritis, bursitis, groin pain, joint crepitation, muscular weakness, musculoskeletal pain, osteolysis, pain in extremity, soft tissue necrosis, tendonitis, decubitus ulcer, joint dislocation reduction, hematoma.No further information provided regarding specifics, severity or the interventions provided for the adverse events.No mention of debris or bearing wear.The article does not specify root cause or the anatomical location of the osteolysis.

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.Product complaint # (b)(4).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 will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9339492
• MDR Text Key: 184546175
• Report Number: 1818910-2019-115017
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

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 FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/18/2019
• Supplement Dates Manufacturer Received: 12/16/2019
• Supplement Dates FDA Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention