MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CERAMAX CERAMIC INSERT 28 X 60; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS

Catalog Number	121889660
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/24/2015
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Clinical adverse event received for deep infection of total hip arthroplasty.Doi: (b)(6) 2015; doe: (b)(6) 2015; (left hip).
Additional Manufacturer Narrative
Product complaint # (b)(4).
Event or Problem Description
Revision operative notes ((b)(6)/2015) stated that there was evidence of infection; surgeon elected to do incision and drainage, with ceramic femoral head exchange, but not exchange of the ceramic acetabular liner.There was no evidence of loose components.Only the femoral head was revised.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.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 28 X 60
• Common Device Name: PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8082589
• Report Number: 1818910-2018-75857
• Device Sequence Number: 268198
• Product Code: KWA
• UDI-Device Identifier: 10603295012719
• UDI-Public: 10603295012719
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/03/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 121889660
• Device Lot Number: 3623557
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 12/03/2018; 12/11/2018
• Initial Report FDA Received Date: 11/17/2018
• Supplement Report FDA Received Date: 12/07/2018; 12/12/2018
• 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 Weight: 110