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); Myocardial Infarction (1969); Thrombosis/Thrombus (4440)

Event Date 03/18/2022

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

Article entitled "a workflow change in anterior approach total hip arthroplasty leads to improved accuracy of biomechanical reconstruction without increased risk of complications" written stephanie v.Kaszuba, md, kyle m.Behrens, md, chad b.Anderson, pa-c, and alexander c.Gordon, md published by arthroplasty today on june 14, 2021, was reviewed.The objective of this study was to compare the precision of biomechanical hip reconstruction and clinical outcomes between the femur first (ff) and acetabular first (af) techniques.267 cases involved.135 were ff and 132 were af.Femoral stems involved actis, corail, c-stem, and summit for af.Ff also included a competitor stem besides the 4 stem types listed above.It will be assumed the femoral head was depuy synthes if a depuy synthes femoral stem was implanted.There was no mention of the acetabular cup or liners involved.Adverse events indicated for femur first: 1 patient experienced infection resulting in septic loosening of the acetabular component, which resulted in revision.1 patient acute kidney injury and symptomatic hyponatremia during the post op course.No treatment noted.The above adverse events were not broken out by products used for the ff group.Adverse events indicated for acetabular first: 3 patients experienced infection.In one case, a patient developed a subcutaneous abscess and underwent i&d, as well as exchange of the polyethylene liner and femoral head 3 weeks after initial tha.Another patient experienced wound dehiscence with subsequent cellulitis and was treated with antibiotics and i&d of a seroma cavity 2 months after tha, after which the incision healed completely.The third case did not exhibit gross evidence of infection; however, the patient did experience superficial wound necrosis and returned to the operating room at 5 weeks for i&d and wound closure.1 patient experienced an intra-op calcar fracture, which was fixed with 2 cables.1 patient with substantial femoral anteversion experienced femoral perforation intraoperatively, which was addressed by removing some of the greater trochanter to allow for better femoral access and using a longer prosthesis than originally planned for to bypass the perforation and achieve stability.1 patient experienced a deep vein thrombosis which was treated with rivaroxaban.1 patient experienced a myocardial infarction treated with percutaneous coronary intervention.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Available xray evidence was reviewed.Based in attached photographic evidence, it cannot be determinate a depuy's device failure or malfunction which could contribute to reported event.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot : a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

• 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: 14015825
• MDR Text Key: 288629057
• Report Number: 1818910-2022-06206
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2022

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: 03/18/2022
• Initial Date FDA Received: 04/05/2022
• Supplement Dates Manufacturer Received: 05/11/2022
• Supplement Dates FDA Received: 05/11/2022
• 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