MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 PINNACLE MTL INS NEUT40IDX58OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Catalog Number 121887458

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

Patient Problems Atrial Fibrillation (1729); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Ischemic Heart Disease (2493); Ambulation Difficulties (2544); Pericardial Effusion (3271); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Initial reporter occupation: lawyer.(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

Ppf, pfs and medical records received.Ppf has no allegation.Pfs alleges pain, gain weight, dm, heart issues, walking difficulty, decrease rom, metallosis and patient suspect metal in blood caused memory impairment.After review of medical records, no revision was scheduled due to diabetes and heart condition as well as throat issue, patient could not be intubated and that a revision surgery would be out of the question.Patient also reported concerns about metallosis.Doi: (b)(6) 2008, dor: none reported, left 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: a device manufacturing (mre) review will not be performed even when product/ lot information is known.Per (b)(4) it has been determined that, for the mom platform and related allegations an mre is not required.

• Brand Name: PINNACLE MTL INS NEUT40IDX58OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• 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: 11660959
• MDR Text Key: 245336352
• Report Number: 1818910-2021-07852
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2021

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: 02/28/2013
• Device Catalogue Number: 121887458
• Device Lot Number: 2548854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2021
• Initial Date FDA Received: 04/13/2021
• Supplement Dates Manufacturer Received: 04/28/2021; 08/09/2021
• Supplement Dates FDA Received: 04/28/2021; 08/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2008
• 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: 12/14 ARTICUL 40MM M SPEC-2; PINNACLE 300 ACET CUP 58MM; PINNACLE MTL INS NEUT40IDX58OD; TRI-LOCK BPS SZ 8 STD OFFSET
• Patient Outcome(s): Required Intervention