MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD MODULAR HEAD 42 MM -8MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number 74121242

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

Patient Problems Pain (1994); Arthralgia (2355)

Event Date 11/08/2023

Event Type  Injury  

Event Description

It was reported that, after a thr on the left side performed on (b)(6) 2007, the patient experienced pain.A revision surgery was performed on (b)(6) 2023 removed and replaced the bhr modular head and two (x2) dysplasia cup screws with an oxinium head and bhr dual mobility liner.The current health status of patient is unknown.

Manufacturer Narrative

Internal complaint reference case- (b)(4).

Manufacturer Narrative

H10: updated section h6 (clinical code).H3, h6: it was reported that a left hip revision surgery was performed due to pain.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 alleged modular head was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.No other similar complaints have been identified for the head.However, this will continue to be monitored via routine trending, however it should be noted that this device is no longer sold.In the absence of the actual devices, the production records were reviewed for the head reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.As no device part and batch numbers were provided for investigation of the sleeve, a complaint history review and manufacturing record review could not be performed.If more information is received, this investigation will be reopened.The 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, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.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 contributed to the reported pain and subsequent revision.The patient impact is the reported pain and revision.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.A definitive root cause cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.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: MODULAR HEAD 42 MM -8MM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• 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: 18267476
• MDR Text Key: 329734716
• Report Number: 3005975929-2023-00163
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 03596010503039
• UDI-Public: 3596010503039
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

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: 74121242
• Device Lot Number: 53068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 12/20/2023
• Supplement Dates FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0584-2016
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization