MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 181891 AML HIGH OFFSET LG STAT 16.5MM; HIP FEMORAL STEM

Catalog Number	155403165
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
Der state that the aml 16.5mm high offset stem packaging was cracked and product was not sterile in packaging.
Additional Manufacturer Narrative
Product complaint # : (b)(4).No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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 will be filed as appropriate.

• Brand Name: AML HIGH OFFSET LG STAT 16.5MM
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 181891; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7185589
• Report Number: 1818910-2018-51061
• Device Sequence Number: 16410826
• Product Code: JDI
• UDI-Device Identifier: 10603295058465
• UDI-Public: 10603295058465
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 155403165
• Device Lot Number: CD8BW1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2017
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 01/12/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1