MAUDE Adverse Event Report: DEPUY IRELAND 9616671 DELTA CER HEAD 12/14 36MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-36-310

Device Problems Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problems Host-Tissue Reaction (1297); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Injury (2348); Not Applicable (3189); No Code Available (3191)

Event Date 02/29/2016

Event Type  Injury  

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

Complaint description: patient was revised to address poly wear due to being noncompliant.The acetabular cup was also noted to have been worn.

Event Description

Pinnacle pfs and medical records received.Pfs alleges injury and pain in the lower back.After review of medical records for mdr reportability, the patient was revised due to abnormal polywear and squeaking of the hip.Revision notes reported worn and fractured poly liner, ceramic head was articulating on the metal of the acetabular shell, metal staining in the joint and soft tissues, and large fluid collection of metal-staining dark fluid.There were no lab results provided.Doi: (b)(4) 2015; dor: (b)(6) 2016; right hip.

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.

• 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 IRELAND 9616671; loughbeg, ringaskiddy co.; cork IN ; EI
• MDR Report Key: 7339418
• MDR Text Key: 102403956
• Report Number: 1818910-2018-55120
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033615
• UDI-Public: 10603295033615
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 1365-36-310
• Device Catalogue Number: 136536310
• Device Lot Number: 8113280
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 89