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

Catalog Number	155401150
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); Hypersensitivity/Allergic reaction (1907); Pain (1994); Discomfort (2330); Test Result (2695)
Date of Event	06/09/2014
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.
Event or Problem Description
Complaint description: litigation alleges the patient suffers from pain, discomfort, inflammation, difficulty ambulating, fluid collection and toxic cobalt-chromium metal debris to be released into the tissue.Update rec'd 8/20/2014- pfs and medical records received.Part number provided.After review of the medical records there is no new additional information that would affect the existing mdr decision.The complaint was updated on: 9/10/2014 update ad 30 may 2018: (b)(4) has been re-opened under (b)(4) due to receipt of ppf and sticker sheets.Ppf alleges pseudotumor, metal wear/metallosis and elevated metal ions.The event description has been updated to indicate the allegations as reviewed.Updated product details.Doi: (b)(6) 2010, dor: (b)(6) 2014; (right hip).
Additional 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.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 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.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H10 additional narrative: corrected: h6 (psuedotumor and metallosis).

• Brand Name: AML SM 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: 7702674
• Report Number: 1818910-2018-64796
• Device Sequence Number: 19015647
• Product Code: JDI
• UDI-Device Identifier: 10603295058250
• UDI-Public: 10603295058250
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/25/2018

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: 155401150
• Device Lot Number: C38JB1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 09/10/2018; 09/05/2019; 11/28/2019
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 09/26/2018; 09/05/2019; 12/24/2019
• 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: 51 YR
• Patient Weight: 86