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

Catalog Number UNK HIP FEMORAL HEAD

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

Patient Problems Unspecified Infection (1930); Limb Fracture (4518); Joint Laxity (4526); Insufficient Information (4580)

Event Date 05/12/2020

Event Type  Injury  

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 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: heaven s, perelgut m, vasarhelyi e, howard j, teeter m, lanting b.Fully hydroxyapatite-coated collared femoral stems in direct anterior versus direct lateral hip arthroplasty.Can j surg.2021 mar 26;64(2):e205-e210.Doi: 10.1503/cjs.000920.Pmid: 33769004; pmcid: pmc8064259.Objective and methods: a retrospective study of 778 hips having received depuy corail fully hydroxyapatite-coated collared femoral stems.The study sought to identify the impact of surgical approach for direct anterior approach (daa) compared to direct lateral approach (dla) on post-op femoral stem subsidence and migration over first two years.The authors hypothesized that daa would result in a greater degree of subsidence.Their results, examinations of radiographs for immediate post-op, year 1, and year 2, identified an average subsidence of 1.88 mm on average for daa, compared to 0.47 mm in the dla cohort.The amount of implant varus tilt was slightly greater in the dla group than in the daa group (0.418° versus 0.176°).Results: no statistically significant differences were observed between the cohorts for any of the measurements described at either follow-up time.Surgical approach does not appear to have significantly affected femoral stem migration patterns.Specific product information was not provided for these hips apart from being depuy corail fully hydroxyapatite-coated collared femoral stems.Femoral heads can be assumed to be depuy devices, but the acetabular constructs are unknown.The specific number of patients who experienced some measure of stem subsidence or varus tilt was not provided.The mean subsidence was ~2mm, and mean tilting in varus was ~0.4°.19 revision surgeries were performed as follows (specific details were not provided in any case): 7: for periprosthetic infection.6: for aseptic femoral stem loosening.4: for periprosthetic femur fracture.2: for recurrent hip joint instability.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code 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
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14955830
• MDR Text Key: 295482009
• Report Number: 1818910-2022-12596
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/08/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 08/23/2022
• Supplement Dates FDA Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention