MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL MM48; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Model Number	71335548
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
H10: internal complaint reference: case: (b)(4).
Event or Problem Description
It was reported that, after a left thr surgery was performed due to osteoarthritis on (b)(6) 2022, in which a oxinium fem hd 12/14 32mm -3, a polarstem stem lat.Ti/ha 4 non-cem, a r3 3 hole acet shell mm48 and a r3 0 deg xlpe acet lnr 32mm x 48mm were implanted, the patient died around on (b)(6) 2022.The specific date and reason of the patient's death are unknown.There is no current evidence that suggests a relationship between the implanted devices and the reported decease.
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the devices, could not be returned for evaluation.The clinical/medical investigation concluded that, although requested, no relevant supporting clinical information was provided to assist with the clinical investigation surrounding the circumstances of the patient¿s death.There is no current evidence that suggests a relationship between the implanted s&n devices and the reported decease.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed devices.For the shell, liner and femoral head, a review of the instructions for use documents for total hip systems provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.For the stem, a review of the instructions for use documents revealed a lists of several potential adverse device effects from a hip arthroplasty.Based on the clinical/medical evaluation conclusions, the risk assessment review was not performed as there is no supporting information provided at this time that relates the alleged event to a failure in the devices.A historical review concluded that there are no prior actions related to these products and event.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.No details about the malfunction of the devices were provided, therefore no factors that can contribute can be delineated.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.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.

• Brand Name: R3 3 HOLE ACET SHELL MM48
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17303107
• Report Number: 1020279-2023-01444
• Device Sequence Number: 7261207
• Product Code: MRA
• UDI-Device Identifier: 03596010598226
• UDI-Public: 03596010598226
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: PO30022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2023

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: 71335548
• Device Catalogue Number: 71335548
• Device Lot Number: 21MW00036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2021
• 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: OXINIUM FEM HD 12/14 32MM -3, LOT#:21CM03448; POLARSTEM STEM LAT.TI/HA 4 NON-CEM, LOT#:B2015971; R3 0 DEG XLPE ACET LNR 32MM X 48MM, LOT#:21MM02517
• Outcome Attributed to Adverse Event: Death
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 51 KG