MAUDE Adverse Event Report: DEPUY INT'L LTD. 8010379 AML 15.0 STD 6.3 5/8 STD 12/14; FEMORAL STEM

Model Number	1554-05-000
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); No Code Available (3191)
Date of Event	01/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.(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
Pcf and medical records received.After review of medical records patient was revised to addressed metal on metal soft tissue irritation and reaction.Operative notes indicated increasing pain with a little limp.Upon entering the hip joint itself, abundant amount of orangish fluid was present.No purulence but sort of the typical metal on metal reaction.There was some of usual reactive almost sawdust like tissue in the capsule.There was some corrosion products on the trunnion but no obvious damage itself.Doi: (b)(6) 2004; dor: (b)(6) 2018 left hip.Please see (b)(4) 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.

• Brand Name: AML 15.0 STD 6.3 5/8 STD 12/14
• Common Device Name: FEMORAL STEM
• Manufacturer (Section D): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 9671327
• Report Number: 1818910-2020-03981
• Device Sequence Number: 2912899
• Product Code: LPH
• UDI-Device Identifier: 10603295058526
• UDI-Public: 10603295058526
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K953694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1554-05-000
• Device Catalogue Number: 155405000
• Device Lot Number: W76J41012
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 03/16/2020
• 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: 65 YR