MAUDE Adverse Event Report: SIGNATURE ORTHOPAEDICS PTY LTD LOGICAL CUP LINER; HIP REPLACEMENT PROSTHESIS

Model Number	111-12-5652
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot has been received by signature orthopaedics on the (b)(6) 2021.All the three products part of the lot 71541-1 have been received and are currently handling by signature orthopaedis as per internal procedure.A root case analysis has been performed part of the complaint process and it has been found that a mistake in the choice of the part number was the issue.A deeper analysis would be performed part of the capa opened following the reception of the complaint and the recall process.
Event or Problem Description
A complaint has been raised regarding discrepancy between product part number and label part number by the customer.After investigation, it has been found that parts of lot 71541-1 has been wrongly labelled.

• Brand Name: LOGICAL CUP LINER
• Common Device Name: HIP REPLACEMENT PROSTHESIS
• Manufacturer (Section D): SIGNATURE ORTHOPAEDICS PTY LTD; 7 sirius road; lane cove west, nsw 2066 ; AS 2066
• MDR Report Key: 11735897
• Report Number: 3008262872-2021-00001
• Device Sequence Number: 11572424
• Product Code: LPH
• UDI-Device Identifier: 09348215001056
• UDI-Public: 9348215001056
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K121297
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/28/2021

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 Expiration Date: 10/31/2025
• Device Model Number: 111-12-5652
• Device Lot Number: 71541-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2021
• Initial Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1