MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DUR OPT CER INS 32/52; DURALOC OPTION IMPLANTS : HIP CERAMIC ACETABULAR LINERS

Catalog Number 159964052

Device Problems Difficult to Remove (1528); Noise, Audible (3273)

Patient Problems Pain (1994); Not Applicable (3189); No Code Available (3191)

Event Date 12/28/2017

Event Type  Injury  

Manufacturer Narrative

(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

Der states that on (b)(6) 2017 patient reports no fall but is unable to use her left hip.Present to the er and it was radiographically discovered that the patient ceramic head had fractured.A disturbing situation discovered while they was trying to book the necessary revision component to help fix the ladies hip were the unavailability of a duraloc poly option thus requiring the surgeon to remove a well fix duraloc cup.Along with a catastrophic failure of the ceramic components the surgeon has reported this to the fda.Patient was taken to the or on (b)(6) 2017 and all components except for the metaphyseal sleeve removed.There was extreme difficulty in removing the ceramic liner from the duraloc cup.They are unsure if the failure to the liner was caused prior or after the failure of the head.The duraloc cup was removed with the zimmer cup out and the patient was revised using primary implants.The surgeon chose a metal head and a poly liner.He was also given an option of another more current ceramic on ceramic option but decided against it.They tried to find why the poly was not available, they spoke with the area vice president.He was able to find out that the poly option for the duraloc cup was in transition period created by the fda and depuy.Doi: (b)(6) 2008; dor: (b)(6) 2017; left hip.Surgical delay of 1 hour.

Event Description

Update jan 10, 2018: after review of the medical records: the patient underwent primary surgery on her left hip on (b)(6) 2008.Primary surgery notes were included in the medical records.Revision is stated to be on (b)(6) 2017; revision notes are not included in the available medical records at the time of this review.A preoperative note from (b)(6) 2017 was included and stated revision surgery was needed due to pain, audible squeaking of the hip, and an implant fracture of the head.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.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.

• Brand Name: DUR OPT CER INS 32/52
• Type of Device: DURALOC OPTION IMPLANTS : HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7211771
• MDR Text Key: 97957196
• Report Number: 1818910-2018-51729
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 1/10/2018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/10/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 159964052
• Device Lot Number: 2503826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2017
• Initial Date FDA Received: 01/23/2018
• Supplement Dates Manufacturer Received: 12/28/2017; 01/10/2018; 11/07/2018
• Supplement Dates FDA Received: 01/31/2018; 02/01/2018; 11/22/2018
• Date Device Manufactured: 11/28/2007
• 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: 62 YR