MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number 71335560

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888)

Event Date 10/26/2021

Event Type  Injury  

Manufacturer Narrative

Complaint reference number: (b)(4).

Event Description

It was reported that, after thr surgery had been performed on (b)(6) 2021, the patient experienced acute blood loss anemia.This adverse event started the same day of the surgery and it was treated by transfusion of a packed rbc 1 unit.Patient was recovered.

Manufacturer Narrative

H3, h6: given the nature of the alleged incident, the device, could not be returned for evaluation.The clinical/medical investigation concluded that, acute blood loss anemia is a known risk of any surgery and is related to the surgical procedure and not the device.Therefore, it cannot be concluded the acute blood loss anemia was related to the implant.The patient impact was noted as recovered/resolved.No further assessment is warranted at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems revealed in warnings and precautions that the patient should be advised to report any unusual incidences.Position changes in the components may compromise the durability of the implants.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include post-operative healing issue and/or patient condition.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.

Manufacturer Narrative

H6, health effect - clinical code: updated.

• Brand Name: R3 3 HOLE ACET SHELL 60MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• 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: 17071744
• MDR Text Key: 316660046
• Report Number: 1020279-2023-01236
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598288
• UDI-Public: 03596010598288
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2023

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
• Device Operator: Health Professional
• Device Model Number: 71335560
• Device Catalogue Number: 71335560
• Device Lot Number: 20HW07306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2023
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: 07/17/2023; 07/17/2023
• Supplement Dates FDA Received: 07/18/2023; 07/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 71342800/OXINIUM FEM HD 12/14 28MM +0; 71358207/OR3O DUAL MOBILITY LINER 46/60; 71358221/OR3O DM XLPE INSERT 28/46
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 102 KG