MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 40MM OXINIUM MODULAR HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71342340

Device Problem Insufficient Information (3190)

Patient Problem Joint Dislocation (2374)

Event Type  Injury  

Event Description

It was reported that patient had primary thr in (b)(6) 2018 and patient had a dislocation.

Manufacturer Narrative

A clinical analysis indicated that no clinically relevant supporting documentation was provided; therefore a thorough medical investigation could not be performed.Should clinical documentation become available in the future, the clinical/medical task may be re evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved our investigation cannot proceed.We will continue to monitor for future complaints and investigate further as necessary.If the devices are received in the future, this complaint can be re opened.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Reviewed during mimb.A medical investigation will be performed.Proceed based on information provided and/or available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by dr.(b)(6) on reviewed during mimb.A medical investigation will be performed.Proceed based on information provided and/or available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by dr.(b)(6) on (b)(6) 2019.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: patient information.Surgical procedure/post-operative care review.Device labeling (including technique guides, ifus, etc.) no clinically relevant supporting documentation was provided; therefore a thorough medical investigation could not be performed.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.

• Brand Name: 40MM OXINIUM MODULAR HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8222360
• MDR Text Key: 132233242
• Report Number: 1020279-2019-00077
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 00885556112410
• UDI-Public: 00885556112410
• Combination Product (y/n): N
• PMA/PMN Number: K093363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71342340
• Device Lot Number: 18FM17934
• Date Manufacturer Received: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR