MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 ANTE XLPE LNR 36MM X 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number 71332404

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

Patient Problem Joint Dislocation (2374)

Event Date 05/08/2023

Event Type  Injury  

Manufacturer Narrative

Complaint reference number: case(b)(4).

Event Description

It was reported that, after thr surgery performed on an unknown date, the patient experienced a dislocation.A revision surgery was performed (b)(6) 2023 to replace the r3 ante xlpe lnr 36mm x 58mm and the oxinium 36mm + 4 femoral head.The current health status of patient is unknown.

Manufacturer Narrative

H3, h6.The devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have definitively contributed to the event.The patient impact beyond the reported dislocation and revision cannot be determined and the patient¿s current health status remains unknown.Therefore, no further clinical/medical assessment can be rendered.For the liner, as the part and batch number information provided did not match into the system, a device history record review could not be performed.For the femoral head, a review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the liner, a review of complaint history did not reveal similar events for the listed device over the previous 12 months.The part and batch number information provided did not match into the system, however the review was performed and did not revealed similar events for the batch.This failure mode will be monitored for future complaints for any necessary corrective actions.For the femoral head, a review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for total hip systems revealed that improper neck selection, positioning, looseness of acetabular or femoral components, extraneous bone, penetration of the femoral prosthesis through the shaft of the femur, femoral impingement, periarticular calcification, and/or excessive reaming may increase the risk of dislocations, and subluxation, which may lead to revision surgery.A review of the risk management files 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 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.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 devices 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.

Manufacturer Narrative

Concomitant devices were added.

• Brand Name: R3 ANTE XLPE LNR 36MM X 58MM
• 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: 17017320
• MDR Text Key: 316090891
• Report Number: 1020279-2023-01183
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 00885556308141
• UDI-Public: 00885556308141
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K182535
• 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,Followup
• Report Date: 06/30/2023

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: 71332404
• Device Catalogue Number: 71332404
• Device Lot Number: 22HM30328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 05/29/2023
• Supplement Dates Manufacturer Received: 05/25/2023; 06/28/2023
• Supplement Dates FDA Received: 05/31/2023; 06/30/2023
• 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: 71331956 / LOT# UNKNOWN; 71343604 / LOT# 22LM00347
• Patient Outcome(s): Required Intervention