MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG +4 XLPE ACET LNR 36MM X 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71338560
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A revision surgery was performed due to dislocation.
Additional Manufacturer Narrative
The associated r3 20 deg 4 xlpe acetabular liner and oxonium femoral head 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 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.After repeated requests, smith and nephew has been unable to obtain batch information of the femoral head.There is no information that would suggest the implanted devices failed to meet specifications.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.Our clinical evaluation noted that the x-rays provided show the cup at a steep inclination angle of approx 55 degrees which could be a reason for the recurrent dislocations.Details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported cup shifting and dislocations cannot be confirmed but the cup position is the likely cause.The future impact to the patient beyond the revision cannot be determined.Without the return of the actual product involved and no batch information available for the femoral head, 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 devices or additional information be received, the complaint will be reopened.

• Brand Name: R3 20 DEG +4 XLPE ACET LNR 36MM X 60MM
• 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: 8468064
• Report Number: 1020279-2019-01280
• Device Sequence Number: 11155863
• Product Code: MBL
• UDI-Device Identifier: 03596010598752
• UDI-Public: 03596010598752
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

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 Catalogue Number: 71338560
• Device Lot Number: 09EM15130
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 03/31/2019
• Supplement Report FDA Received Date: 07/02/2019
• 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
• Patient Age: 86 YR