MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER INSERT 28ID X 50OD; HIP ACETABULAR INSERT/LINER

Catalog Number 121883750

Device Problems Fracture (1260); Fitting Problem (2183); Noise, Audible (3273)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 06/14/2016

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.(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

Revision surgeon for this believes that the ceramic liner has not been aligned correctly during the primary procedure.The patient indicated for a "squeaky hip" - upon further investigation it became apparent that the ceramic liner had shattered.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

The initial review of the information made available to the investigation found the product was to specification at the time of manufacturing.This information and products have been sent for further investigation to the ceramic supplier.The supplier will carry out further in-depth analysis to assist in the determination of the root cause.The investigation shall be closed with an interim report and be reopened when the suppliers report is completed.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the complaint, originally (b)(4), was re-opened to add the pe code implant-implant fit mating parts dont fit together.There was no change to the original investigation.No further investigation required.Device history lot: null.Device history batch: null.Device history review: null.

Event Description

Complaint description: revision surgeon for this believes that the ceramic liner has not been aligned correctly during the primary procedure.The patient indicated for a ¿squeaky hip¿ ¿ upon further investigation it became apparent that the ceramic liner had shattered.4 july 2016 update : patient is (b)(6).Height 159.5cm.Weight (b)(6) kgs.Patient lives alone in first floor flat.Horse owner with a cat and a dog.The rest of the information was listed on the original email.

• Brand Name: DELTA CER INSERT 28ID X 50OD
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 5743725905
• MDR Report Key: 5745618
• MDR Text Key: 48054949
• Report Number: 1818910-2016-22045
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121883750
• Device Lot Number: 2399798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 72 YR
• Patient Weight: 63