MAUDE Adverse Event Report: SIGNATURE ORTHOPAEDICS PTY LTD LOGICAL BONE SCREW; HIP REPLACEMENT PROSTHESIS

Model Number	111-12-9135
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Dhr review: manufacturing records were reviewed for manufacturing lots 7c187-1 and 7af9d.All parts were found fully conforming to specification without deviation (attachment 1 and 2).Complaints/capa review: a previous similar complaint had been received from this user (b)(4).No other similar complaints have been received by signature orthopaedics.The devices subject to (b)(4) were manufactured in (b)(6).The devices subject to complaint (b)(4) were manufactured by (b)(6); however, metal shaping activities were performed at the (b)(6).This is the first such complaint for athlone manufactured product.The screw holes in the logical cup were designed to allow angulation while retaining the screw head.A design evaluation was performed as per (b)(4), and demonstrated that the logical cup screw holes retain the logical bone screw under worst case conditions when operated as intended.The returned device has been evaluated.Damage to the screw head and cup hole were noted and were consistent with the screw being pressed through the screw hole.The incident was the result of material deformation.Additional usage details are required to determine the cause of the deformation.
Event or Problem Description
The middle hole is where dr.(b)(6) screwed the 35 mm screw into the bone.The screw went through the hole and was all the in the bone.He then got the screw and shell out successfully.He asked for a new 48 shell.I gave him a new one however he says the shell outer part wasn't sticking well to the bone.So we decided to go up to a 50.I put the screw and shell in one bag and the other shell in which it wasn't attaching to the bone in the other.A replacement cup size 50 was used and was successful.

• Brand Name: LOGICAL BONE SCREW
• Common Device Name: HIP REPLACEMENT PROSTHESIS
• Manufacturer (Section D): SIGNATURE ORTHOPAEDICS PTY LTD; 7 sirius road; lane cove west, new south wales 2066 ; AS 2066
• MDR Report Key: 8721033
• Report Number: 3008262872-2019-00002
• Device Sequence Number: 13918414
• Product Code: LPH
• UDI-Device Identifier: 09348215001292
• UDI-Public: 9348215001292
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121297
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2019

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: 10/31/2018
• Device Model Number: 111-12-9135
• Device Lot Number: 7AF9D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 06/21/2019
• 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