MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 CERAMAX CERAMIC INSERT 36 X 56; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS

Catalog Number	121887656
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Tissue Damage (2104)
Date of Event	06/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Concomitant med products: pinnacle sector ii cup 56mm 121722056; pinn can bone screw 6.5mmx35mm 121735500; delta cer head 12/14 36mm +8.5 136536330; unknown femoral stem.
Event or Problem Description
(b)(6).Clinical adverse event received for acetabular component loosening, failure to ingrow.Event is serious.Event is related to both device and procedure.Doi: (b)(6) 2016; doe: (b)(6) 2018; 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 56
• Common Device Name: PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7726402
• Report Number: 1818910-2018-65346
• Device Sequence Number: 11039621
• Product Code: MRA
• UDI-Device Identifier: 10603295012535
• UDI-Public: 10603295012535
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2018

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: 03/31/2019
• Device Catalogue Number: 121887656
• Device Lot Number: 7883835
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 12/21/2018
• 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: 98