MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE HA CTD ACET SHELL 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71331948
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had primary hip replacement on 6-7-2020.Revision surgery was performed due to recurrent dislocations (x-ray attached).Cup/liner/head were removed.Surgeon changed version and longer head to restore offset/leg length.Same size cup/liner inserted with screw 35mm length and central screw hole cover.Ox +4 head 32mm implanted (longer than previous).Surgeon commented reason for revision was due to cup malpositioning (too anteverted) and not enough offset/length.Not a product fault.
Additional Manufacturer Narrative
It was reported that the patient had primary hip replacement on 6-7-2020.Revision surgery was performed due to recurrent dislocations.Cup/liner/head were removed.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.A clinical analysis noted that two un-dated x-rays have been provided for review and did not add to the investigation.No additional medical documents were received for investigation.Therefore no further medical assessment can be performed at this time.Surgeon stated the failure was due to cup malpositioning (too anteverted) and not enough offset/length, and not a product failure.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: R3 3 HOLE HA CTD ACET SHELL 48MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10423615
• Report Number: 1020279-2020-04036
• Device Sequence Number: 19567660
• Product Code: MBL
• UDI-Device Identifier: 03596010597724
• UDI-Public: 03596010597724
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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 Model Number: 71331948
• Device Catalogue Number: 71331948
• Device Lot Number: 20BM09974
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OXINIUM FEM HD 12/14 32MM +0; R3 20 DEG +4 XLPE ACET LNR 32MM X 48MM; REF INTERFIT THRD HOLE COVER; REF SPHER HEAD SCREW 35MM; OXINIUM FEM HD 12/14 32MM +0; R3 20 DEG +4 XLPE ACET LNR 32MM X 48MM; REF INTERFIT THRD HOLE COVER; REF SPHER HEAD SCREW 35MM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention