MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER CERAMIC; CERAMIC ACETABULAR LINER

Catalog Number UNK HIP ACETABULAR LINER CERAM

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Nerve Damage (1979); Thrombosis/Thrombus (4440); Joint Laxity (4526)

Event Date 01/01/2022

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

This complaint is from a literature source.Literature citation: ma hy, sun jy, du yq, gao zs, shen jm, li tj, zhou yg.Model to predict need for subtrochanteric shortening osteotomy during total hip arthroplasty for crowe type iv developmental dysplasia.Med sci monit.2020 oct 25;26:e926239.Doi: 10.12659/msm.926239.Pmid: 33099571; pmcid: pmc7594583.Objective/methods/study data: one hundred forty-nine patients (186 hips) with crowe type iv ddh who underwent total hip arthroplasty (tha) with s-rom implants from january 2010 to november 2018 were included in the study.The acetabular components were placed at the true acetabulum and the trial femoral component was inserted.Reduction then was attempted and if it could not be achieved, ssot was performed.Using multivariable cox regression analysis, a model was constructed that included age, sex, surgical history, use of a cone- or triangle-shaped sleeve, secondary acetabulum formation, and percentage of dislocation as predictive factors for ssot.The prostheses used in the patients were modular s-rom stems (depuy) and cementless acetabular cups.Duraloc option cups (depuy) were used in 33 hips, while pinnacle cups (depuy) were used in 153 hips.A 28-mm ceramic head was used in all procedures.Figure 1 and 2 have illustrative radiographic images of implants but no adverse events noted within captions.Adverse event(s) and provided interventions (acetabular cup product platform is not specified for the adverse events): qty 2 nerve palsy with symptoms disappearing within 1 year and intervention not specified by article.Qty 5 femur fractures and intervention not specified by article.Qty 1 deep venous thrombosis and intervention not specified by article.Qty 9 postoperative dislocations and intervention not specified by article.Qty 1 obvious leg length discrepancy of 2.5 cm and treated with revision.

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 ACETABULAR LINER CERAMIC
• Type of Device: CERAMIC ACETABULAR LINER
• 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: 15092946
• MDR Text Key: 296468441
• Report Number: 1818910-2022-13795
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER CERAM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2022
• 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