MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 MULTI HOLE ACETABULAR SHELL 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number 71338667

Device Problem Unstable (1667)

Patient Problem Injury (2348)

Event Date 08/21/2017

Event Type  Injury  

Event Description

It was reported a right hip revision surgery due to severe pain and instability.

Manufacturer Narrative

The devices, intended for use in treatment, were not returned for evaluation.A clinical evaluation was conducted and per the surgical technique, the acetabular component is to be impacted with 15-20° of anteversion and 40-45° inclination angle.However, the operative report indicated the acetabular component was implanted at approximately 20-25° anteversion and during the revision the cup was noted to be anteverted significantly.It is unknown to what extent the significant anteversion impacted the patient¿s pain.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Some potential probable causes of the event could include, malposition of the device or improper device selection.Please refer to the instructions for use for recommendations on proper use of the device to prevent future reoccurrence of the reported event.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 56MM
• 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: 9101209
• MDR Text Key: 159451932
• Report Number: 1020279-2019-03444
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 00885556021934
• UDI-Public: 00885556021934
• Combination Product (y/n): N
• PMA/PMN Number: K092386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71338667
• Device Catalogue Number: 71338667
• Device Lot Number: 17AW17757
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention