MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN ORTHOPAEDIC RECONSTRUCTION DEV; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL

Catalog Number UNKNOWN

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

Patient Problem Joint Dislocation (2374)

Event Date 01/01/1901

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient underwent revision surgery due to dislocation.A biolox delta head with 28mm/46mm dual mobility head (from s&n) was involved in this event.No additional information was provided.No more details are available at this time.

Manufacturer Narrative

The affected complaint device, used in treatment, was not returned for evaluation.Therefore, a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.According to clinical/medical evaluation, for the first revision (report number: 1020279-2020-06096), the clinical information provided, of the elevated metal ion levels, the pseudotumor and metal staining may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure.For the second and third revisions and interventions, the root cause cannot be definitively concluded.It is unknown if the combination of components, the documented pelvic deformity and the poor tissue and bone quality contributed to the issues.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore, no medical assessment can be performed at this time.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.Internal complaint reference number: case-2020-00033532-1.

Manufacturer Narrative

H10: this complaint (our reference: (b)(4)/mdr reference: 1020279-2020-07504) has been reassessed based on the existing evidence made available to the manufacturer.This record was initially created to investigate a revision surgery performed on (b)(6) 2020 due to recurrent dislocations.However, based on the surgical history of the patient and the operative notes made available to the manufacturer, it has been determined that no smith+nephew devices have been involved following the revision surgery conducted on (b)(6) 2020 due to a fractured echelon stem and a sustained periprosthetic femoral fracture (our reference: (b)(4)/mdr reference: 1020279-2020-06096).Given that the medical documentation available indicates that the revision surgery performed on (b)(6)2020 due to recurrent dislocations involved zimmer-biomet devices, it has been determined that this event does not fulfill reporting requirements per the provisions listed in 21 cfr §803.We now consider this record closed, and no further investigation is warranted at this moment.

• Brand Name: UNKN ORTHOPAEDIC RECONSTRUCTION DEV
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, 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: 11017854
• MDR Text Key: 221707430
• Report Number: 1020279-2020-07504
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2021
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female