MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF LNR 28X50-52 20 DEG SZ E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 71742850

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, after a thr was performed on (b)(6) 2003, patient presented an unknown adverse event.This adverse event was solved by a revision surgery on (b)(6)2023, in which liner and head were exchanged.Health status of the patient is unknown.

Manufacturer Narrative

Given the nature of the alleged incident, the shell and stem could not be returned for evaluation.The liner and head components were not returned; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the limited information provided the definitive root cause of the reported adverse event that led to the revision cannot be determined.The procedure was resumed, without any delay, changing the liner and head.Leg lengths were equal on the table and surgeon was satisfied with new implants prior to closure.The impact to the patient was the unknown adverse event, the revision, and the expected transient recovery period.No further clinical/medical assessment is warranted at this time.For the shell, stem and femoral head, the devices' specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, risk management files and prior actions could not be performed.For the liner, the batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the liner.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.A review of the risk management file for the liner's part number 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 the liner and the event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.No details about the cause of the revision surgery were provided, therefore no factors that can contribute can be delineated.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.

• Brand Name: REF LNR 28X50-52 20 DEG SZ E
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 18426891
• MDR Text Key: 331824729
• Report Number: 1020279-2024-00004
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932755
• 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
• Report Date: 02/13/2024

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 Catalogue Number: 71742850
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 02/09/2024
• Supplement Dates FDA Received: 02/13/2024
• 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