MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 AML LG STATURE 12.0MM; AML IMPLANT : HIP FEMORAL STEM

Catalog Number	155402120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/07/2004
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 claim and medical records, it was indicated that during the primary surgery, as the real stem was being impacted, a small anterior unicortical crack occurred on the femur.A cerclage cable was then placed around the proximal femur.The stem was noted to be stable.Right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.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 LG STATURE 12.0MM
• 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: 8528519
• Report Number: 1818910-2019-91066
• Device Sequence Number: 19522742
• Product Code: JDI
• UDI-Device Identifier: 10603295058342
• UDI-Public: 10603295058342
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2019

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: 155402120
• Device Lot Number: Y3HF31000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 05/24/2019
• 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: 54 YR