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

Catalog Number	121887660
Medical Device Problem Codes	Fitting Problem (2183); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/26/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7266184
• Report Number: 1818910-2018-53319
• Device Sequence Number: 19288617
• Product Code: MRA
• UDI-Device Identifier: 10603295012559
• UDI-Public: 10603295012559
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 121887660
• Device Lot Number: 5472563
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 09/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR