MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD 50/28MM BH DUAL MOBILITY INSERT; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number 74120158

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

Patient Problems Nerve Damage (1979); Hip Fracture (2349); Unequal Limb Length (4534)

Event Date 05/05/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

Us legal: bilateral patient.It was reported that, after a left bhr surgery was performed on (b)(6) 2007 due to progressing disabling of both hips, pain, and avascular necrosis, the patient suffered left hip impingement, for which left revision surgery was conducted on (b)(6) 2007.After that event, the patient experienced heterotopic ossification and elevated metal ions, for which a second revision surgery was performed on (b)(6) 2021.Subsequently, the patient experienced partial sciatic nerve palsy, leg length discrepancy and left hip greater trochanteric fracture.This adverse event was treated with a third revision surgery on (b)(6) 2021.The patient's current status is unknown.

Manufacturer Narrative

Section h3, h6: it was reported that left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.A review of the historical complaints data for the 50/28mm bh dual mobility insert was performed using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.No other similar complaints were identified to involve this batch and for the part number and the reported failure mode.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.The available medical documents were reviewed.With the information provided, the clinical root cause of the reported leg length discrepancy and left hip greater trochanteric fracture cannot be confirmed; however, the mixed manufacture construct cannot be ruled out as a contributing factor to the reported events.The s&n endoprostheses ifu (81007036 rev.G 2020-11) instructs ¿do not mix components from other manufacturers.¿ the partial sciatic nerve palsy is a known complication of hip replacement surgery and is related to the procedure and not the device.It cannot be concluded the nerve palsy is associated with a mal performance of the implant.Based on the available information we can confirm the reported complaint, however without further information our investigation remains inconclusive, and a definitive root cause cannot be determined for the reported leg length discrepancy and left hip greater trochanteric fracture.The partial sciatic nerve palsy is a known complication of hip replacement surgery and is related to the procedure and not the device.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: 50/28MM BH DUAL MOBILITY INSERT
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14487326
• MDR Text Key: 292487081
• Report Number: 3005975929-2022-00331
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 03596010502605
• UDI-Public: 03596010502605
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171934
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 74120158
• Device Catalogue Number: 74121650
• Device Lot Number: B1813674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/24/2022
• Supplement Dates Manufacturer Received: 09/01/2022
• Supplement Dates FDA Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2018
• 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: ACETLR CUP HAP 58MM W/ IMPTR
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male