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

Catalog Number UNK HIP ACETABULAR LINER CERAM

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 01/18/2022

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

Literature article entitled ¿long-term results of delta ceramic-on-ceramic total hip arthroplasty" written thomas j.Blumenfeld, md, joel politi, md, sean coker, tammy o¿dell, william hamilton, md.Published in arthroplasty today; published online 18 january 2022 was reviewed.The article's purpose was to report the minimum 10-year follow-up of both the 28-mm and 36-mm articulations concentrating on survivorship and bearing complications including fracture and squeaking.Patient data: patients aged 20 to 75 years undergoing primary tha for noninflammatory degenerative joint disease.Depuy products: pinnacle cementless porous coated cup; aml, prodigy, summit, porocoat, duofix, srom, or corail cementless stems.It is also reasonable to conclude the ceramic head and liner were also depuy product.Adverse events: (4) hip noise ¿ no treatment indicated (2) dislocation -treatment of 1 revision and 1 closed reduction (3) ceramic liner fracture ¿ treated with revision (1) pain ¿ 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: 14986352
• MDR Text Key: 295686372
• Report Number: 1818910-2022-12816
• Device Sequence Number: 1
• Product Code: MRA
• 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

• Date FDA Received: 07/12/2022
• 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: 07/13/2022
• 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