MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71335552

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Injury (2348)

Event Date 02/12/2019

Event Type  Injury  

Event Description

After thr, the screw was passed by the acetabular cup.No delay reported, no device backup required.

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: R3 3 HOLE ACET SHELL 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8409099
• MDR Text Key: 138423598
• Report Number: 1020279-2019-01025
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598240
• UDI-Public: 03596010598240
• Combination Product (y/n): N
• PMA/PMN Number: K070756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71335552
• Device Lot Number: 18LM02336
• Date Manufacturer Received: 02/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention