MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AML LG STATURE 15.0MM; HIP FEMORAL STEM/SLEEVE

Catalog Number	155402150
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Tissue Damage (2104); No Code Available (3191)
Date of Event	12/07/2012
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.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
Event or Problem Description
Litigation alleges that the patient suffers from pain, discomfort, inflammation, popping/snapping, and large amounts of toxic cobalt chromium metal ions and particles.Update: 2/27/2013 pfs was received from legal, medical records were received from legal, and part/lot information was identified.Records are available for further review.Update sep 18, 2017: litigation record received.There is no new allegation.Added complainant information.Added stem due to alleged toxic metal ions.Updated product information.This complaint was updated on oct 5, 2017.
Additional Manufacturer Narrative
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
(b)(4).
Event or Problem Description
Pfs and medical records received.Pfs alleges injuries including but are not limited to device failure and associated disability, tissue damage including muscle and bone loss caused by metallosis and alval requiring painful and dangerous hip revision surgery, ongoing pain, suffering and disability.Symptoms began in 2005.It was also alleged that plaintiff suffers from decreased mobility, lack of comfort and pain.Medical records report no new information.
Additional Manufacturer Narrative
Product complaint # (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision depuy synthes 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.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: null.Device history batch null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up 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).

• Brand Name: AML LG STATURE 15.0MM
• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6957826
• Report Number: 1818910-2017-26691
• Device Sequence Number: 13594799
• Product Code: JDI
• UDI-Device Identifier: 10603295058373
• UDI-Public: 10603295058373
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/18/2017

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 Expiration Date: 03/10/2010
• Device Catalogue Number: 155402150
• Device Lot Number: ZH7BX1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2017
• Supplement Date Received by Manufacturer: 12/18/2017; 01/12/2018; 05/31/2019; 08/02/2019; 09/16/2019
• Initial Report FDA Received Date: 10/18/2017
• Supplement Report FDA Received Date: 12/19/2017; 02/02/2018; 06/04/2019; 08/12/2019; 12/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 136