MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 6IN AML SM STATURE 10.5MM; AML IMPLANT : HIP FEMORAL STEM

Catalog Number	155401106
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Ppf and implant records received.Pinnacle plaintiff profile form alleges pulmonary embolism after first revision.Doi cup, screws, and stem: (b)(6) 2009; doi liner and head: (b)(6) 2014; dor all products: none; left 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, a follow-up medwatch will be filed as appropriate.

• Brand Name: 6IN AML SM STATURE 10.5MM
• Common Device Name: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7540094
• Report Number: 1818910-2018-60380
• Device Sequence Number: 18863467
• Product Code: JDI
• UDI-Device Identifier: 10603295058212
• UDI-Public: 10603295058212
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2018

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 Expiration Date: 06/11/2018
• Device Catalogue Number: 155401106
• Device Lot Number: CX3B11000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 06/27/2018
• 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