MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 AML LG STATURE 15.0MM; AML IMPLANT : HIP FEMORAL STEM

Catalog Number	155402150
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Discomfort (2330); Injury (2348); Not Applicable (3189)
Date of Event	12/03/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Complaint description: patient was revised to address pain.Update apr 23, 2018: pinnacle litigation records received.Litigation alleges friction and wear between the cobalt-chromium metal head and metal liner caused large amounts of toxic cobalt-chromium metal ions and particles to be released into the patients blood and tissue and bone surrounding the implant.Patient suffered from pain, discomfort, personal injuries and damages, mental pain, inflammation and tissue and bone loss and other related diseases.Added stem due to alleged toxic cobalt-chromium metal ion levels.Updated the revision hospital and added new associated contact.Doi: (b)(6) 2008; dor: (b)(6) 2014; (right hip).
Additional Manufacturer Narrative
Pc-(b)(4).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.
Additional 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 or Problem Description
Ppf alleges metallosis.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Additional 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.

• Brand Name: AML LG STATURE 15.0MM
• Common Device Name: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7530540
• Report Number: 1818910-2018-60132
• Device Sequence Number: 13799308
• Product Code: JDI
• UDI-Device Identifier: 10603295058373
• UDI-Public: 10603295058373
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/23/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 155402150
• Device Lot Number: CR6ED1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 10/17/2018; 08/18/2019; 12/09/2019
• Initial Report FDA Received Date: 05/21/2018
• Supplement Report FDA Received Date: 10/18/2018; 08/19/2019; 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 83