MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 MULTI HOLE ACETABULAR SHELL 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71338664

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 06/05/2018

Event Type  Injury  

Event Description

Revision surgery was performed due to dislocation.The surgeon deemed that the cause of this failure was cup malalignment.The surgeon does not fault the device.The product is not available.No more information available.

Manufacturer Narrative

The associated complaint device was not returned.A clinical evaluation was conducted and it was reported a revision surgery was performed due to dislocation.The surgeon deemed that the cause of this failure was cup malalignment.No clinical relevant documents were provided to conduct a thorough medical assessment, nor will the product be provided for evaluations.The impact to the patient beyond the revision cannot be determined.No further clinical/medical assessment is warranted at this time.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Device history record review confirmed that all released parts met specifications applicable at the time of production.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.We consider this investigation closed.

• Brand Name: R3 MULTI HOLE ACETABULAR SHELL 50MM
• 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: 7657629
• MDR Text Key: 112990916
• Report Number: 1020279-2018-01263
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 00885556020630
• UDI-Public: 00885556020630
• Combination Product (y/n): N
• PMA/PMN Number: K092386
• 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: 11/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 71338664
• Device Lot Number: 17HW18138
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention