MAUDE Adverse Event Report: DEPUY IRELAND 9616671 PINNACLE SECTOR II CUP 54MM; HIP ACETABULAR CUP

Catalog Number 121722054

Device Problems Disassembly (1168); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); No Information (3190); No Code Available (3191)

Event Date 04/27/2015

Event Type  Injury  

Event Description

Dislocation of poly insert from acetabular shell.Needed revision of poly insert.

Manufacturer Narrative

Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).

Manufacturer Narrative

Additional narrative: this complaint remains under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.

Manufacturer Narrative

A review of the manufacturing records identified no anomalies and a worldwide complaint search identified no previous complaints for the relevant lot numbers.A review of the x-rays, medical records and the returned products by our bio engineering suggests that the disassociation may have been initiated by a traumatic event.No other information related to the root cause was identified.The customer did not report a device defect.From the information reviewed in this report it is unlikely that there was a manufacturing fault.No corrective action is required.Post market surveillance is per sep-419.The complaint was found to be unjustified.The root cause was undetermined.The product will be retained in a secure storage area.No corrective action is required.Post market surveillance is per sep-419.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

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

Event Description

Update rec'd 05 july 2015 - the patient's medical records were received.Medical records were reviewed for mdr reportability.According to the medical records the patient began to experience pain and squeaking in their hip after falling on (b)(6) 2015.During an office visit on (b)(6) 2015 it was noted the patient's left lower limb was shortened by a centimeter.Upon revision, the patient's liner was found to be subluxed inferiorly and the femoral head was articulating directly with the acetabular shell.A reasonable amount of metallosis was noted throughout the hip.Post operatively the patient was noted to have an inflamed and draining incision, and underwent a debridement but no implants were removed.At this time there is no new information that would change the existing mdr decision.The complaint was updated on: 04/08/2015.

• Brand Name: PINNACLE SECTOR II CUP 54MM
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4865167
• MDR Text Key: 16991707
• Report Number: 1818910-2015-24221
• 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,foreign,health professi
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/05/2015

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 Catalogue Number: 121722054
• Device Lot Number: 8032537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/05/2015
• Initial Date FDA Received: 06/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2014
• 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: 70 YR
• Patient Weight: 70