MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AML HIGH OFFSET LG STAT 16.5MM; AML IMPLANT : HIP FEMORAL STEM

Catalog Number	155403165
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Weakness (2145); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); Not Applicable (3189)
Date of Event	09/05/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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.
Event or Problem Description
New unity record created in order to update etq complaint number (b)(4).New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint.- litigation alleges that the patient suffers from large amounts of toxic amounts of cobalt chromium metal ions and particles to be released into the patients blood, tissue, and bone surrounding the implant.It is also alleged that the patient suffers from pain, discomfort, limited mobility, and weakness.Pfs was received from legal, medical records were received from legal, and part/lot information was identified.Records are available for further review.Sales rep has reported a revision due to instability.Complaint was updated (b)(6) 2017.(b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets received.There is no new allegation and revision reported.Added stem due to previously alleged toxic amounts of cobalt chromium metal ions.Added lawyer and law firm.Doi: (b)(6) 2008 - dor: (b)(6) 2017(right hip).

• Brand Name: AML HIGH OFFSET LG STAT 16.5MM
• Common Device Name: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7832281
• Report Number: 1818910-2018-68120
• Device Sequence Number: 16535355
• Product Code: JDI
• UDI-Device Identifier: 10603295058465
• UDI-Public: 10603295058465
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/08/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 155403165
• Device Lot Number: B3LFX1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 79