MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE ACET SHELL 56MM

Model Number	71331856
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Hip Fracture (2349)
Date of Event	06/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed on (b)(6) 2020 due to a right side acetabular fracture.Femoral head, acetabular liner and shell were revised.Date of initial surgery was (b)(6) 2020.
Event or Problem Description
It was reported that a revision surgery was performed due to a right side acetabular fracture.
Additional Manufacturer Narrative
It was reported that hip revision surgery was performed.During the revision, the r3 shell, r3 liner, modular head and sleeve were removed.The stem remained implanted.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the r3 shell, r3 liner, modular head and sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for the r3 shell.This will continue to be monitored.Similar complaints have been identified for the r3 liner, modular head and sleeve.However, as the devices are no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed, but if additional clinically relevant materials are later received the case may be re-opened for further evaluation.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: R3 0 HOLE ACET SHELL 56MM
• Common Device Name: R3 0 HOLE ACET SHELL 56MM
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10662775
• Report Number: 1020279-2020-05332
• Device Sequence Number: 3551598
• Product Code: MRA
• UDI-Device Identifier: 03596010597618
• UDI-Public: 03596010597618
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K070756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2021

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: Lay User/Patient
• Device Expiration Date: 07/13/2019
• Device Model Number: 71331856
• Device Catalogue Number: 71331856
• Device Lot Number: 09GM08099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 10/28/2020; 11/04/2021
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 11/04/2020; 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BHR HEAD 74222144, LOT 09AW21489; MODULAR SLEEVE +8MM 12/14 / 74222400 / 07FW12490; SYN POR HO FEM COM SZ 13 / 71306113 / 09KM15760
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 81 KG