MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AML SM STATURE 16.5MM; AML IMPLANT : HIP FEMORAL STEM

Catalog Number	155401165
Medical Device Problem Codes	Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994); Tissue Damage (2104); Discomfort (2330); Joint Disorder (2373); Test Result (2695); No Code Available (3191)
Date of Event	11/16/2009
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Occupation: attorney.
Event or Problem Description
Litigation alleges that the patient suffers from severe pain, discomfort, inflammation, and a popping/snapping sensation.Update 10/18/2012: records indicate that the patient was revised because of infection.Patient was revised to address chronic pain, discomfort, and infection.Update rec'd 5/12/2014 - litigation papers received.In addition to what was previously reported, litigation alleges the patient suffers from toxic cobalt-chromium metal ions and particles to be released into the blood, tissue and bone.Update ad 26 feb 2019: receipt of ppf and medical records.In addition to what were previously alleged, ppf alleged pseudotumor.After review of medical records, patient was revised to address infected left total hip arthroplasty, increasing pain in the left hip, patient had a workup, which was consistent with loosening.Patient experienced pain, loosening of the prosthesis, and subsidence.Operative reported there was scarring within superficial and deep tissues.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.No device associated with this report was received for examination.A review of the device manufacturing records (dhr) was already performed as part of this investigation.Please see the attached associated complaint for those results.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Per internal procedures, the event information and any investigational inputs received as part of required follow up were reviewed.For this investigation, no immediate action was required as no alleged deficiency with the device(s) was identified.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : null.Device history batch : null.Device history review : null.

• Brand Name: AML SM STATURE 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: 8416184
• Report Number: 1818910-2019-87127
• Device Sequence Number: 19198924
• Product Code: JDI
• UDI-Device Identifier: 10603295058267
• UDI-Public: 10603295058267
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2019

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: 155401165
• Device Lot Number: ZK2GK1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 11/21/2019
• 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: 46 YR
• Patient Weight: 107