MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 30MM; PRSTHSIS,HIP,SMI-CNSTRND,UNCMNTD,METAL/POLYMR,NON-PORS,CALICUM-PHSPHTE

Catalog Number	71332530
Medical Device Problem Codes	Calibration Problem (2890); Unintended Movement (3026)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	01/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after a total hip replacement procedure, post operative film showed that the screw had gone completely through the shell.No delay reported.No revision surgery performed.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and based on the information provided the root cause of the acetabular screw penetration cannot be definitively determined, the device remains implanted.The patient impact cannot be completed as it is unknown if migration could occur or migration of the shell at this time.No further medical assessment can be rendered at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.
Additional Manufacturer Narrative
Information was received that changed the type of incident to a malfunction.Post op film showed that the screw had gone completely through the shell with no direct impact to the patient.

• Brand Name: REF SPHER HEAD SCREW 30MM
• Common Device Name: PRSTHSIS,HIP,SMI-CNSTRND,UNCMNTD,METAL/POLYMR,NON-PORS,CALICUM-PHSPHTE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8278472
• Report Number: 1020279-2019-00288
• Device Sequence Number: 13834880
• Product Code: MEH
• UDI-Device Identifier: 03596010460479
• UDI-Public: 03596010460479
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K990666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2019

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: 71332530
• Device Lot Number: 18HB00121
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 01/02/2019; 09/28/2019
• Initial Report FDA Received Date: 01/25/2019
• Supplement Report FDA Received Date: 03/07/2019; 11/14/2019
• 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: Other; Required Intervention