MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX54OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Model Number 1218-87-354

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Sepsis (2067); Swelling (2091); Discomfort (2330); Injury (2348); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 04/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pinnacle claim submission form and medical records received.After review of medical records, the patient was revised to address sepsis and pain.Patient complains of decreased range of motion and tenderness.Approximately 50 ml of gross purulence was encountered upon incision.Doi: (b)(6) 2009.Dor: (b)(6) 2018, (left hip).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional 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.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.

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.Update 01/09/2020 received did not have any additional details to be added in investigation.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : a complaint device manufacturing (dhr) reviews will not be performed.Per wi-3430 it has been determined that should related reports be identified a dhr review is not required.Corrected: g1.

• Brand Name: PINNACLE MTL INS NEUT36IDX54OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 9109839
• MDR Text Key: 162835141
• Report Number: 1818910-2019-105919
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K073504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/03/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2014
• Device Model Number: 1218-87-354
• Device Catalogue Number: 121887354
• Device Lot Number: 2971857
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 09/24/2019
• Supplement Dates Manufacturer Received: 10/02/2019; 01/09/2020; 03/18/2021
• Supplement Dates FDA Received: 10/02/2019; 01/10/2020; 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 81