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

Catalog Number 71342340

Device Problem Unstable (1667)

Patient Problem Joint Dislocation (2374)

Event Date 06/04/2018

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to left anterior hip dislocation with recurrent instability.

Manufacturer Narrative

The associated complaint device was not returned.The clinical/medical team concluded, the intraoperative findings of reddish colored fluid, synovitis, metallosis and bone loss are re consistent with findings associated with metal debris.Without the supporting analysis of the explanted components, the source of the reported metallosis cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.Additionally, the patient¿s morbid obesity and the use of a zimmer acetabular component with a smith + nephew implant, which is contraindicated, and cannot be ruled out as a contributing factors for the dislocation and subsequent 2nd lt tha revision.It cannot be concluded that the reported reactions/events were associated with a mal-performance of the smith + nephew implant.The patient impact beyond the revision pain/healing cannot be determined.No further clinical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken 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: 8446379
• MDR Text Key: 139666566
• Report Number: 1020279-2019-01153
• 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
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

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 Expiration Date: 04/06/2024
• Device Catalogue Number: 71342340
• Device Lot Number: 14DM07685
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 03/22/2019
• Supplement Dates Manufacturer Received: 03/04/2019
• Supplement Dates FDA Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR