MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 MULTI HOLE ACETABULAR SHELL 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number 71338663

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 02/07/2020

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to pain, swelling, disassociation of the cup and dislocation of the insert.

Manufacturer Narrative

The devices, used in treatment were not returned for evaluation, reporting event could not be confirmed.A clinical evaluation was conducted and confirms per subsequent email, no relevant clinical information will be provided.Without the request clinical information, a thorough medical investigation cannot be rendered.Should any additional medical information be provided this complaint will be re-assessed.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.

• Brand Name: R3 MULTI HOLE ACETABULAR SHELL 48MM
• 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: 9718898
• MDR Text Key: 180750763
• Report Number: 1020279-2020-00595
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 00885556021941
• UDI-Public: 00885556021941
• Combination Product (y/n): N
• PMA/PMN Number: K092386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71338663
• Device Catalogue Number: 71338663
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention