MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ALTRX NEUT 40IDX56OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1221-40-056

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Erythema (1840); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Injury (2348); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); Not Applicable (3189); No Code Available (3191)

Event Date 11/09/2017

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pfs and medical records received.Pfs alleges pain, infection, physical injuries, inflammation, decreased range of motion and mobility.After the review of medical records for mdr reportability, the patient had a second revision to address infection.Revision notes reported large amount of purulence, pulsavac irrigation performed as well as curette debriding of the soft tissues, head and liner were exchanged, and antibiotic beads were placed.Aspiration performed showed staphylococcus epidermis gram positive cocci, developed progressive symptoms and erythema.Doi: (b)(6) 2017; dor: (b)(6) 2017; left hip (2nd revision).Patient is bilateral.

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.

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.Udi: (b)(4).

Event Description

Ppf alleges elevated metal ions.

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.Device history lot: hg1879.Device history review: no anomalies or deviations were found.Patient code: no code available (3191) is used to capture surgical intervention.E3 initial reporter occupation: lawyer.

• Brand Name: ALTRX NEUT 40IDX56OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7498222
• MDR Text Key: 107716140
• Report Number: 1818910-2018-59172
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295393344
• UDI-Public: 10603295393344
• Combination Product (y/n): N
• PMA/PMN Number: K132959
• 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: 04/12/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 1221-40-056
• Device Catalogue Number: 122140056
• Device Lot Number: HG1879
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/12/2018
• Initial Date FDA Received: 05/09/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 04/11/2019; 10/29/2020
• Supplement Dates FDA Received: 08/29/2018; 04/24/2019; 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 106