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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374); Physical Asymmetry (4573)

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.

Event Description

An article/literature was received entitled "role of a bone conserving short stem femoral component in revision total hip arthroplasty: a case report".Literature article entitled "role of a bone conserving short stem femoral component in revision total hip arthroplasty: a case report" written by babaji thorat, avtar singh, and rajeev vohra published by journal of clinical orthopaedics and trauma published online/accepted by publisher 9/29/2020 was reviewed.The article's purpose was to discuss "the revision of cemented conventional femoral stem using a bone conserving short-stem femoral implant with circumferential metaphyseal fixation, which is seldom reported in the literature." data was compiled from one (b)(6) year-old male who presented to the emergency department with right hip pain.Cement manufacturer was not identified.The case study indicated the patient underwent a right hip revision to address pain, limb asymmetry, dislocation, acetabular cup loosening at the bone-to-cement interface, cup migration, and cup poly wear.All components were revised.The charnley femoral stem was well-fixed but revised to accomodate the 22.225 mm femoral head.The patient was revised to competitor products.The primary operation was indicated as approximately 18 years ago.X-ray images can be found on pages 2, 3, and 4 of the literature article.Depuy products: charnley femoral stem, unknown depuy femoral head, unknown depuy acetabular cup, unknown depuy acetabular liner.Adverse events: acetabular cup loosening at the bone-to-cement interface, migration, and cup poly wear.Pain, limb asymmetry, dislocation.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Visual examination of the provided x-ray images confirmed the reported dislocation.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 : a worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.

• 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: 12333563
• MDR Text Key: 267044135
• Report Number: 1818910-2021-18025
• 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: foreign,health professional,l
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2021

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: 07/26/2021
• Initial Date FDA Received: 08/17/2021
• Supplement Dates Manufacturer Received: 09/08/2021; 10/15/2021
• Supplement Dates FDA Received: 09/20/2021; 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK HIP FEMORAL STEM CHARNLEY; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS
• Patient Outcome(s): Required Intervention