MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN MULTIHOLE W/GRIPTION 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121730050
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Codes	Pain (1994); Not Applicable (3189)
Date of Event	04/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 patient underwent a difficult primary total hip back in (b)(6) 2017 where a revision multihole pinnacle cup was implanted.The patient had a large cyst/defect in his acetabulum requiring large amounts of bone grafts and screws.A pinnacle altrx +4/10 degree was implanted along with summit stem and a 32+1 head.All components were very good choice for this patient.A few months later patient complained of painful hip revision surgery was required.Upon inspection intraoperatively it seemed the liner had not fully locked into pinnacle cup.A new liner was placed along with a new head.Fixation of liner was thoroughly inspected and locked properly into cup.Doi: (b)(6) 2017; dor: (b)(6) 2018; unknown 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, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN MULTIHOLE W/GRIPTION 50MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7530259
• Report Number: 1818910-2018-60106
• Device Sequence Number: 16492997
• Product Code: LPH
• UDI-Device Identifier: 10603295009979
• UDI-Public: 10603295009979
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K071784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2018

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: No Information
• Device Catalogue Number: 121730050
• Device Lot Number: H81865
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 05/21/2018
• Supplement Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention