MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN SPECTRON EF IMPL; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number UNKN01100300

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

Patient Problem Joint Dislocation (2374)

Event Date 02/24/2021

Event Type  Injury  

Event Description

It was reported that underspecified revision surgery was conducted.There is no information regarding the explanted devices, the reason for the revision surgery nor the patient outcome.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKN SPECTRON EF IMPL
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11685256
• MDR Text Key: 246010531
• Report Number: 1020279-2021-03184
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01100300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention