MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 25MM; PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE

Catalog Number	71332525
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that upon reviewing post op xrays immediately following closure on a primary hip replacement, it was found that one (possibly both) screws implanted during the case are disassociated with the r3 cup.Two screws were put in respectively.Each look to be intact from the post op x-ray.This suggests that the screws went through the r3 cup.Neither the fellow or attending operating applied abnormal amounts of force when implanting the screws.
Additional Manufacturer Narrative
The associated r3 3 hole acetabular shell and reflection spherical head cancellous screws were not made available for investigation.However, device details were provided.Thus, a review of the manufacturing records and complaint history was conducted.The review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of complaint history of the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.As devices were not returned for analysis, the failure mode cannot be determined.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.Without the return of the actual products involved, our investigation of this report is inconclusive.Our clinical evaluation noted the provided x-rays confirms the reported issue.A procedural variance, additional trauma, bone quality, body habitus, or comorbidities as contributing factors to the reported event cannot be ruled out.It is currently unknown if the patient is experiencing pain.The future impact to the patient cannot be determined.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: REF SPHER HEAD SCREW 25MM
• 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: 8417292
• Report Number: 1020279-2019-01058
• Device Sequence Number: 1846052
• Product Code: MEH
• UDI-Device Identifier: 03596010460462
• UDI-Public: 03596010460462
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K990666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2019

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: 71332525
• Device Lot Number: 18HB00117
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 05/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1