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 Arrhythmia (1721); Foreign Body Reaction (1868); Headache (1880); Pyrosis/Heartburn (1883); Itching Sensation (1943); Pain (1994); Rash (2033); Synovitis (2094); Tinnitus (2103); Discomfort (2330); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/17/2020

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

It was reported by the patient that " i had my right hip & knee replaced (b)(6) 2006 and my left hip replaced (b)(6) 2007.I began having left hip problems in 2016.I went to the original operating doctor to have it checked.At that time he did not find a solution for my discomfort.He did, however take a cobalt test at that time.It came back at 7.2.This year he took another cobalt test on (b)(6) 2020 and the results were 16.4.After review of medical record patient was revised to address metallosis.Revision notes stated that an inflammatory fluid in the joint and staining of the synovium and synovitis was encountered.Burnishing on the femoral components was noted.Head and liner were removed.Added patient's medical history, laboratory data, dor, revision hospital, and patient's dob.Corrected patient's initials and surgeon.Doi: (b)(6) 2006 - dor: (b)(6) 2020 (right hip).

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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• 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 46581 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11474700
• MDR Text Key: 243122971
• Report Number: 1818910-2021-04997
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2009
• Device Model Number: 1218-87-354
• Device Catalogue Number: 121887354
• Device Lot Number: 1235914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP.; ARTICULEZE M HEAD 36MM +1.5.; PINNACLE 300 ACET CUP 54MM.; SUMMIT POR TAPER SZ5 HI OFF.
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female