MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TNDM BP SHL/XLPE LNR 43OD 26ID; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 71325043

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 06/22/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that, after a hip hemiarthroplasty which had been performed on (b)(6) 2023, the patient experienced pain and dislocation.This adverse event was treated via revision surgery on (b)(6) 2023, in which all the implants were exchanged with competitor devices; an s-lock stem was used.It was noticed that the posterior wall of the acetabulum was defective and a support ring was utilized, the bone quality was also reported to be poor.Current health status of the 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 stated that the requested medical documentation was not available.The patient current health status is unknown.Correspondence revealed that ¿the posterior wall of the acetabulum was noted to be missing and a support ring was utilized¿.Provided details surrounding the implantation, reported adverse event, and revision are limited; therefore, no clinical factors could be definitively concluded to have contributed to the event.The patient impact beyond the reported symptoms with missing acetabulum and subsequent revision with a support ring using competitor components cannot be determined.No further medical assessment can be rendered 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 devices did not reveal similar events for the listed devices.A review of the instructions for use documents for endoprostheses systems revealed that care must be taken to assess the viability of the acetabular hyaline cartilage and the presence of any irregularity, anomaly, or surface configuration which may predispose to subluxation and/or dislocation of the prosthesis.This has been identified as a warning.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, 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.

• Brand Name: TNDM BP SHL/XLPE LNR 43OD 26ID
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• 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: 17322545
• MDR Text Key: 319060885
• Report Number: 1020279-2023-01451
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 00885556019689
• UDI-Public: 885556019689
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123598
• 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: 08/28/2023

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 Catalogue Number: 71325043
• Device Lot Number: 23AM14634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 08/24/2023
• Supplement Dates FDA Received: 08/28/2023
• Date Device Manufactured: 01/24/2023
• 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: 71302608 / LOT# 22KM05804; 75002748 / LOT# F2221683
• Patient Sex: Female