MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 AML HIGH OFFSET LG STAT 13.5MM; AML IMPLANT : HIP FEMORAL STEM

Catalog Number	155403135
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Date of Event	03/07/2019
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.Device was used for treatment, not diagnosis.(b)(4).
Event or Problem Description
It was reported that the patient suffered a fracture distal to her aml stem, so the stem was removed and replaced with a revision stem.The liner was also exchanged.Original surgery date/location unknown.Doi: unknown; dor: (b)(6) 2019; right hip.
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.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: AML HIGH OFFSET LG STAT 13.5MM
• 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: 8460718
• Report Number: 1818910-2019-88844
• Device Sequence Number: 11516486
• Product Code: JDI
• UDI-Device Identifier: 10603295058441
• UDI-Public: 10603295058441
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 155403135
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 04/17/2019
• 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