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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 02/01/2021

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

Literature article entitled ¿early results of total hip arthroplasty for t nnis grade 3 hip osteoarthritis in patients with spondyloepiphyseal dysplasia " written by ke yan, zhang qiang, ma yunqing, li rujun, tao ke, gui xiange, li kepeng, zhang hong, and lin jianhao.Published in journal of peking university; published online 01 feb 2021 was reviewed.The article's purpose was to investigate the early efficacy and possible impact of total hip arthroplasty for the treatment of t nnis grade 3 hip osteoarthritis in sed (spondyloepiphyseal dysplasia) patients.Patient data: nine patients (12 hips) underwent tha for sed.There were 6 males and 3 females, aged (38.22 ± 7.55) years (28 to 50 years), height (159.89 ± 10.25) cm (142-173 cm).Of these patient, only 1 experienced an adverse event - 36 year old female.It is noted that implants in the study were a combination of depuy and competitor products.Depuy products: the articles dictates ¿johnson & johnson ceramic liner - ceramic femoral head depuy c-c.Based on this information, it is reasonable to conclude that the hip construct (head, liner, stem and cup) are depuy product, though it is unknown what product line.Adverse event for 36 year old female.Intermuscular venous thrombosis ¿ treated with immobilization and strengthening anticoagulation medication.

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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14772063
• MDR Text Key: 294506454
• Report Number: 1818910-2022-11390
• 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: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 08/09/2022
• 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