MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. PINNACLE 300 ACET CUP 60MM; HIP ACETABULAR CUP

Catalog Number 121703060

Device Problems Use of Device Problem (1670); Malposition of Device (2616)

Patient Problems Necrosis (1971); Pain (1994); Discomfort (2330); Joint Swelling (2356)

Event Date 03/18/2013

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Litigation alleges that the patient suffers from pain, discomfort, inflammation, popping/grinding sensations, limited mobility and large amounts of toxic cobalt chromium metal ion particles to be released into the blood, tissue, and bone.Update rec'd 9/17/2014 - pfs and medical records received.After review of the medical records there is no new additional information that would affect the existing mdr decision.The complaint was updated on: 10/7/2014.Update 3/16/2015-pfs and medical records received.After review of the medical records for mdr reportability, lab results from (b)(6) 2013 indicated the metal ion levels were below 7ppb.There is no new additional information that would affect the investigation.The complaint was updated on:3/27/2015.Update 12/24/2015- pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Pfs reported pain.Medical records reported adverse soft tissue reaction to metal debris, joint effusion, synnovial inflammation, moderate taper corrosion and dense fibrotic tissue with necrosis.Radiograph reports noted the acetabular component to be slightly overabducted and heterotopic ossification present.The cup will be added to the complaint for malposition.The stem will be added to complaint for corrosion.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

Depuy considers the investigation closed.Should additional information be received the investigation will be reopened.

Event Description

Update12/02/16 ¿ pfs and medical records received.After review of the medical records for mdr reportability, there is no new additional information that would affect the existing invstigation.

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.

• Brand Name: PINNACLE 300 ACET CUP 60MM
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 5377430
• MDR Text Key: 36318618
• Report Number: 1818910-2016-11198
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK001534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/02/2016

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: 05/26/2010
• Device Catalogue Number: 121703060
• Device Lot Number: ZV3FC1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/24/2015
• Initial Date FDA Received: 01/19/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 08/03/2020
• Supplement Dates FDA Received: 02/24/2016; 12/20/2016; 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 132