MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 58MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL

Model Number 71335758

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

Patient Problems Muscle Weakness (1967); Joint Dislocation (2374)

Event Date 12/11/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a thr surgery was performed on (b)(6) 2022, the patient experienced dislocation and muscle weakness.This adverse event was treated by a revision surgery on (b)(6) 2022, in which a r3 20 deg xlpe acet lnr 36mm x 5 was explanted and a constrained liner implanted.Patient's current health status is unknown.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, after a total hip replacement (b)(6) 2022, the patient experienced dislocation and muscle weakness.Patient had a revision surgery on (b)(6) 2022, in which a r3 20 deg xlpe acet lnr 36mm x 5 was explanted and a constrained liner implanted.It is noted, ¿the surgeon asked for no investigation as he does not fault the implant.For this reason, he is not releasing any surgery notes, x-rays or patient information.¿ patient is a 93yr old male.His primary total hip replacement surgery was for fracture neck of femur after he fell.Since then, his health has declined.Patient's current health status is unknown.Additional information is not available; therefore, there were no clinical factors found which would have contributed to the reported events.Patient impact beyond the reported events cannot be determined with the limited information provided.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 that dislocation may result from improper selection of the neck length and cup, stem positioning, muscle looseness and/or malpositioning of components, this has been identified as warnings and precautions.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 product specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.Factors that could contribute to the reported event include traumatic injury, patient anatomy, postoperative care or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should the device or 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 20 DEG XLPE ACET LNR 36MM X 58MM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL
• 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: 16098357
• MDR Text Key: 306653251
• Report Number: 1020279-2023-00036
• Device Sequence Number: 1
• Product Code: LZY
• UDI-Device Identifier: 03596010598363
• UDI-Public: 03596010598363
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K896580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71335758
• Device Catalogue Number: 71335758
• Device Lot Number: 21LM10679
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• Date Device Manufactured: 11/15/2021
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 93 YR
• Patient Weight: 82 KG