MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX58OD; HIP ACETABULAR INSERT/LINER

Catalog Number 121887458

Device Problems Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Loss of Range of Motion (2032); Depression (2361); No Code Available (3191)

Event Date 03/02/2017

Event Type  Injury  

Manufacturer Narrative

This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient claim received.Patient alleges he suffers from ions "creeping up" and pain.Update 11/14/2016 litigation received.Per depuy's complaint handling procedure, all litigation is reported.Complaint was updated 11/27/2016.Update may 12, 2017: legal medical records received.In addition to what was previously alleged, pfs alleges ringing in both ears, pain in lower back, cognitive issues with becoming forgetful, angry, depressed, lack of mobility, loss of range of motion and decreased desired activities.After review of medical records for the mdr reportability, revision notes stated that a small amount of fluid in the joint was noted.No signs of synovitis and pseudotumor or loosening.Mri shows large joint effusion with extension into the trochanter bursa.Operative notes indicates no signs of trunnionosis.Lab results for metal ions were below 7ppb.Product codes and lot numbers were provided.This complaint was updated on may 19, 2017.

Manufacturer Narrative

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. .

Event Description

Ppf alleges metal wear/metallosis.

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).

• Brand Name: PINNACLE MTL INS NEUT40IDX58OD
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6583879
• MDR Text Key: 75719678
• Report Number: 1818910-2017-18473
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K062426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2015
• Device Catalogue Number: 121887458
• Device Lot Number: 3079903
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 92