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

Patient Problems Seroma (2069); Joint Dislocation (2374)

Event Date 10/29/2021

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

This complaint is from a literature source.The following literature cite has been cintean r, pankratz c, hofmann m, gebhard f, schütze k.Early results in non-displaced femoral neck fractures using the femoral neck system.Geriatr orthop surg rehabil.2021 oct 29;12:21514593211050153.Doi: 10.1177/21514593211050153.Pmid: 34733579; pmcid: pmc8559200.Objective and methods: the purpose of this study is to compare the outcome of 63 elderly patients with multiple comorbidities presenting with undisplaced femoral neck fractures that were treated with 34 depuy corail/bipolar hemiarthroplasties (ha) or 29 synthes fns between june 2018 and june 2020.This complaint will capture the events associated with the depuy ha.The events associated with the synthes fns are captured separately.All events associated with the patient¿s preexisting comorbidities are excluded from the complaint.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: depuy hemiarthroplasty consisting of a corail stem and an unspecified depuy self-centering bipolar femoral head.Adverse event(s) and provided interventions associated with depuy devices: 3 seromas: 2 treated with revision and 1 treatment unspecified.1 recurrent dislocation treated with conversion to tha.

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.Attached mirf and guidance form.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.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: 14306922
• MDR Text Key: 290974373
• Report Number: 1818910-2022-08311
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 05/06/2022

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: 04/20/2022
• Initial Date FDA Received: 05/06/2022
• Supplement Dates Manufacturer Received: 04/20/2022; 05/20/2022
• Supplement Dates FDA Received: 05/07/2022; 05/23/2022
• 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