MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM L/+8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71343608
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from a post-market clinical follow-up activity that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
On a post-market clinical follow-up activity for cpcs hip systems, it was reported that, after undergoing right revision thr on (b)(6) 2021 due to loose tha (non-smith+nephew initial implants), one (1) patient experienced a fall at home on (b)(6) 2021 that led to right hip dislocation.This adverse event was treated by performing a closed reduction with traction.The patient presented a second dislocation that was solved the same way (reported under case (b)(4)).
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the devices could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the limited information provided, the surgeon decision to use a shorter stem, and the 45 degrees of anteversion in the revision surgery likely cause of the reported fall and joint dislocation.Therefore, a procedural variance/user error could not be ruled out.Neither the procedure report nor x-rays were provided.The impact to the patient beyond the reported closed reduction with traction is unknown.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the distal centralizer, a review of complaint history for the part number over the past 26 months and for the batch number based on historical data of the device did not reveal similar events.For the femoral head and stem, the complaint history review revealed a similar event for the listed devices over the previous 26 months, but no similar events for the batches 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 dislocation has been identified in warnings and precautions, that may result from improper selection of the neck length and cup, stem positioning, muscle looseness and/or malpositioning of components.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 this products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.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.H11.Corrected information in h6 ((b)(4)).

• Brand Name: OXINIUM FEM HD 12/14 36 MM L/+8
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 16325391
• Report Number: 1020279-2023-00292
• Device Sequence Number: 12736480
• Product Code: JDI
• UDI-Device Identifier: 03596010477293
• UDI-Public: 03596010477293
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K022958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Study,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

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
• Operator of Device: Health Professional
• Device Model Number: 71343608
• Device Catalogue Number: 71343608
• Device Lot Number: 20LM01074
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CPCS COCR PRIM 12/14 SZ3(PN:71312363,LN:19HM03209); CPCS DIST CNT SZ 14MM(PN:71312414,LN:20HM02372)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female