MAUDE Adverse Event Report: SIGNATURE ORTHOPAEDICS PTY LTD SIGNATURE CERAMIC FEMORAL HEAD

Model Number	111-152-621
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject incident occured in foreign country.
Event or Problem Description
As reported to signature orthopaedics by distributor: "this morning one of our reps opened a 32 (s) ceramic femoral head with lot number 78560 but inside was a 28 (s) femoral head instead.".

• Brand Name: SIGNATURE CERAMIC FEMORAL HEAD
• Common Device Name: FEMORAL HEAD
• Manufacturer (Section D): SIGNATURE ORTHOPAEDICS PTY LTD; 7 sirius road; lane cove west, nsw 2066 ; AS 2066
• MDR Report Key: 7236540
• Report Number: 3008262872-2018-00001
• Device Sequence Number: 19122118
• Product Code: MEH
• UDI-Device Identifier: 09348215001926
• UDI-Public: 09348215001926
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121297
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/02/2018

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: Physician
• Device Expiration Date: 10/31/2022
• Device Model Number: 111-152-621
• Device Lot Number: 78560
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1