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 Calcium Deposits/Calcification (1758); Unspecified Infection (1930); Physical Asymmetry (4573)

Event Date 01/03/2022

Event Type  Injury  

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.The device catalog number is unknown; therefore, udi is unavailable.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: tellefsen ra, ugland t, bjørndal mm, ugland s, pripp ah, nordsletten l.Increased risk of high-grade heterotopic ossification using direct lateral approach versus a muscle-sparing anterolateral approach to the hip: radiological results from a randomised trial in patients with a femoral neck fracture treated with hemiarthroplasty.Hip int.2022 may 18:11207000221097639.Doi: (b)(4).Epub ahead of print.Pmid: 35585787.Objective and methods: authors studied 150 patients who received uncemented hemiarthroplasties to treat femoral neck fractures, with randomized selection for anterolateral approach (ala) or direct lateral approach (dla).The authors sought to study the impact on component placement and formation of heterotopic ossification, based on whether a muscle sparing or direct lateral surgical approach was utilized (75 patients included in each group).Measurements included leg-length discrepancy, femoral offset, femoral stem position, canal fill ratio and the presence of heterotopic ossification after 12 months.Implants utilized in all patients were depuy corail collared straight stems with hydroxyapatite coating, paired with depuy self-centering bi-polar head and 28mm femoral head.Individual patient case or demographic data was not provided, nor were specific adverse issues or complications broken out by specific patients.Results: at 12 months follow-up, one patient in the ala group was diagnosed with brooker grade 4 heterotopic ossification¿patient had post-op infection in first post-op month, requiring two revision surgeries (details not provided).5 patients in the dla group had brooker grade 3 heterotopic ossification.There was an equal distribution of patients who developed brooker grades 2 (dla = 6 and ala = 5) and grades 1 (dla = 11 and ala = 8).The dla groups higher brooker grade results were considered statistically significant.Post-op radiographic exams noted that significant leg-length discrepancy (lld >= 10mm) was present in dla = 6, and ala = 9.A decrease in femoral offset >= 15% was identified in (dla = 31) and (ala = 29), and valgus/varus stem positioning noted in (dla = 18) and (ala = 11) in lateral view.Apart from the patient with post-op infection who was revised twice, no other medical or surgical complications were reported.At the twelve month follow-up, 11 patients in the dla group had expired, while 13 patients in the ala group had expired¿no suggestion was made that the patients¿ deaths were related to their surgical procedures or implants.Hemiarthroplasty performed in the direct lateral approach resulted in a higher incidence of brooker grade 3 heterotopic ossification.Otherwise, results support equal restoration and component placement with either approach.

• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15484697
• MDR Text Key: 300586125
• Report Number: 1818910-2022-18680
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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
• Report Date: 09/26/2022

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: 09/08/2022
• Initial Date FDA Received: 09/26/2022
• 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