MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 AML HIGH OFFSET LG STAT 15.0MM; AML IMPLANT : HIP FEMORAL STEM

Model Number	1554-03-150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Sepsis (2067); Swelling (2091); Discomfort (2330); No Code Available (3191)
Date of Event	11/10/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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
After review of medical record, patient was revised to address infection.Revision notes stated that a large amount of fluid was seen within subcutaneous space.Patient underwent an irrigation and debridement of the left wound and large vac application.Patient experienced pain, swelling, tenderness, active rom moderately impaired, and severe sepsis.Doi: (b)(6) 2016, (head,liner,stem).Doi: (b)(6) 2016, (cup, screw, apex).Dor: (b)(6) 2016, left hip.
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.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: AML HIGH OFFSET LG STAT 15.0MM
• Common Device Name: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 9909169
• Report Number: 1818910-2020-09829
• Device Sequence Number: 3272664
• Product Code: JDI
• UDI-Device Identifier: 10603295058458
• UDI-Public: 10603295058458
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

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 Model Number: 1554-03-150
• Device Catalogue Number: 155403150
• Device Lot Number: 234514
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 05/08/2020
• 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: 54 YR