MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 DELTA CER HEAD 12/14 36MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number 136536310

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Pain (1994); Injury (2348); No Code Available (3191)

Event Date 03/10/2017

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.For any product information received.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.

Event Description

Patient was revised to address pain and a ceramic liner fracture.Update (b)(6) 2017 interaction record attached.Update (b)(6) 2017.Medical records received.Patient was revised to address grinding noise in the hip.Added the femoral head on the product.On the operative note it was stated that the head was scored but it was intact also, the liner was fractured in multiple planes.In addition, c-arm does confirmed there are some additional small fragments that are more inferior.All fragments and shards were removed.This complaint was updated on (b)(6) 2017.

Manufacturer Narrative

Investigation summary the information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, will be filed as appropriate.

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

Litigation records and sticker sheets received.In addition to what was previously alleged, it was stated that the patient experienced difficulty sleeping due to pain and injury.It was also stated that the surgeon was unable to retrieve all the broken ceramic liner shards.Doi: (b)(6) 2016 - dor: (b)(6) 2017 (right hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.H10 additional narrative:  added: h6 (patient,device).No code available is used to capture surgical interventiona nd surgery prolonged.

• Brand Name: DELTA CER HEAD 12/14 36MM +1.5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 6569348
• MDR Text Key: 75260290
• Report Number: 1818910-2017-18123
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K031803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/18/2017

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 Expiration Date: 09/30/2021
• Device Catalogue Number: 136536310
• Device Lot Number: 8398876
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/18/2017
• Initial Date FDA Received: 05/16/2017
• Supplement Dates Manufacturer Received: 11/20/2018; 12/27/2018; 08/04/2020
• Supplement Dates FDA Received: 11/23/2018; 01/10/2019; 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR