MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL MM46; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71335546
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a cup migration.
Additional Manufacturer Narrative
The associated r3 hole acetabular shell was not returned for evaluation.A clinical investigation noted that based on the statement provided which stated that the ¿patient has cancer and has low bone quality causing cup to migrate¿, this could indicate that the failure was not the failure of the device.The future impact to the patient beyond the revision cannot be concluded.No further clinical /medical investigation is warranted this time.A review of complaint history on the list part revealed no additional complaints for this failure mode with the same batch number.Our investigation included a review of the manufacturing records from the manufacturer which did not reveal any deviation from the standard manufacturing processes.Without the return of the actual product involved, our investigation of this report is inconclusive.No additional actions are being taken at this time.However we will continue to monitor for future complaints and investigate further as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.
Additional Manufacturer Narrative
The associated r3 3hole acetabular shell was not returned for evaluation.A clinical evaluation was conducted and noted that all documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.Based on the statement provided on the complaint, it was reported that the ¿patient has cancer and has low bone quality causing cup to migrate¿.This could indicate that the failure was not the failure of the device but the actual migration cannot be concluded.The future impact to the patient beyond the revision cannot be concluded.No further clinical /medical investigation is warranted this time.A review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: R3 3 HOLE ACET SHELL MM46
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7485980
• Report Number: 1020279-2018-00848
• Device Sequence Number: 16634969
• Product Code: MBL
• UDI-Device Identifier: 03596010598219
• UDI-Public: 03596010598219
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K070756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/19/2018

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 Expiration Date: 06/14/2026
• Device Catalogue Number: 71335546
• Device Lot Number: 16FM13208
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 04/17/2018; 04/17/2018; 04/17/2018
• Initial Report FDA Received Date: 05/04/2018
• Supplement Report FDA Received Date: 06/26/2018; 12/19/2018; 12/19/2018
• 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