MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 30MM; PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE

Catalog Number	71332530
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a total hip case, the screw passed by the acetabular cup.
Additional Manufacturer Narrative
The associated r3 3 hole acetabular shell and reflection spherical head cancellous screw were not returned for evaluation.Therefore a product analysis could not be performed.However, device details were provided for the liner.Thus a review of the manufacturing records and complaint history was conducted.The review of for the manufacturing records for the liner did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the part revealed no prior complaints for the listed failure mode with the same batch number.Our clinical evaluation noted that no relevant supporting clinical information has been provided to assist with a clinical investigation.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.Without the return of the actual product involved, our investigation of this report is inconclusive and the exact cause of the reported failure was not able to be determined.We consider this investigation closed.Should the devices or additional information be received, the complaint will be reopened.

• Brand Name: REF SPHER HEAD SCREW 30MM
• Common Device Name: PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8409189
• Report Number: 1020279-2019-01028
• Device Sequence Number: 13516150
• Product Code: MEH
• UDI-Device Identifier: 03596010460479
• UDI-Public: 03596010460479
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K990666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71332530
• Device Lot Number: 18EM13200
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 07/02/2019
• 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: Hospitalization; Required Intervention