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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Joint Dislocation (2374); Physical Asymmetry (4573)

Event Date 09/08/2021

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

Article entitled ¿notching of the neck after acetabular constraint necessitating femoral component revision "written by john c.Bonano, md, abiram bala, md, foster chen, md, derek f.Amanatullah, md, phd, stuart b.Goodman, md, phd, published by arthroplasty today on 08 september 2021, was reviewed.This case report of a 75-year-old-woman, demonstrates a rare occurrence of femoral neck notching with the use of a constrained acetabular liner.Excessive component anteversion may be a risk factor for notching, as it resulted in increased impingement of the posterior neck of the femoral component.On 02/2015 patient had left hip arthroplasty.Depuy pinnacle cup and summit stem were placed.(it can be assumed depuy head/liner were placed).Case 3: on july 2019, the patient had pain, felt a ¿pop¿ while bending over, and had leg length discrepancy.Patient had a left hip aspiration, which was devoid of growth.Radiographs were reported to show superior dislocation of the femoral component with intact constrained acetabular liner and locking ring.During the procedure, the surgeon observed metallosis, granulation tissue, and a dislocation of the hip.The acetabular cup was stable and not revised.The liner showed wear consistent with impingement posteriorly.The stem was revised due to significant wear and notching.An extended trochanteric osteotomy was done to remove the stem.Depuy liner was implanted along with competitor stem and unknown head.(fig 2).Contributing factors likely included excessive anteversion of the femoral and acetabular components which resulted in increased impingement.

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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 14986837
• MDR Text Key: 295691835
• Report Number: 1818910-2022-12832
• 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: 07/12/2022

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?: Yes
• 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: 06/22/2022
• Initial Date FDA Received: 07/12/2022
• Supplement Dates Manufacturer Received: 08/19/2022
• Supplement Dates FDA Received: 08/19/2022
• 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