MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL HEAD METAL ARTICUL/EZE; METAL FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD METAL ART

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Hematoma (1884); Unspecified Infection (1930); Joint Dislocation (2374)

Event Date 02/01/2022

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 bordes m, viste a, fauvernier m, mercier m, chaudier p, severyns m, fessy mh.Outcomes and survival of a modern dual mobility cup and uncemented collared stem in displaced femoral neck fractures at a minimum 5-year follow-up.Orthop traumatol surg res.2022 feb;108(1):103164.Doi: 10.1016/j.Otsr.2021.103164.Epub 2021 dec 1.Pmid: 34863956.Objective and methods: the purpose of this retrospective study using a competitor dual mobility cup paired with a cemented stem to treat 244 femoral neck fractures between 2013 and 2014 was to determine (1) confirm the low dislocation rate in this indication, (2) assess other surgical complications, in particular periprosthetic fractures, (3)ensure that these benefits are maintained over time, at a minimum follow-up of 5 years and, (4) assess the rate of revision of the implants.The occurrence of dislocation, periprosthetic fracture, infection of the surgical site, loosening, reoperation and revision were investigated.All dm cups and liners were competitor products paired with a corail cementless stem and articul-eze 22.225 mm or 28 mm cocr femoral head.The authors concluded that the use of this type of implant is a reliable treatment for femoral neck fractures.This complaint will capture the events associated with the depuy stem and head.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: corail stem, articul-eze head.Adverse event(s) and provided interventions associated with depuy devices: 5 dislocations (1 secondary to falling, see fig.3 on pp.4, 1 secondary to competitor cup malpositioning): all treated with closed reduction.8 infections treated with i & d or revisions of head and liner; 3 femoral ppf treated with stem revision; 2 hematoma treated with surgical debridement.

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: UNK HIP FEMORAL HEAD METAL ARTICUL/EZE
• Type of Device: METAL 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: 15040245
• MDR Text Key: 296052658
• Report Number: 1818910-2022-13160
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/18/2022

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 METAL ART
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/18/2022
• 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