MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 CERAMAX CERAMIC INSERT 36 X 60; HIP CERAMIC ACETABULAR LINERS

Catalog Number 121887660

Device Problems Fitting Problem (2183); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 01/26/2018

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

Der states that patient dislocated hip and was taken back to surgery to put back in place.When he dislocated a second time surgeon decided to take the patient to surgery to remove the neutral ceramic liner and replace with a more constrained +4, 10 degrees.He removed the liner, cup and head.He replaced with a new cup, liner and head.Cup had to be removed due the inability to remove the liner from the cup.Doi: (b)(6) 2017; dor: (b)(6) 2018; left 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CERAMAX CERAMIC INSERT 36 X 60
• Type of Device: HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7266184
• MDR Text Key: 99900751
• Report Number: 1818910-2018-53319
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295012559
• UDI-Public: 10603295012559
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• 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
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121887660
• Device Lot Number: 5472563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2018
• Date Device Manufactured: 07/23/2013
• 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: 42 YR