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

Catalog Number 71306611

Device Problems Loss of Osseointegration (2408); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Event Description

It was reported that a revision hip surgery was performed due to pain.

Manufacturer Narrative

Additional information received.

Event Description

It was reported that patient needed a revision surgery due to stem loosening that was causing pain.

Manufacturer Narrative

The associated complaint devices were not returned.The clinical/medical team concluded, no clinical supporting documents were provided to conduct a thorough assessment of the reported issue.Should documents become available it is possible we will be able to do a medical investigation.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 parts revealed no prior complaints for the listed batches.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.

Event Description

It was reported that after an initial right tha on (b)(6) 2017 due to a labral tear.Plaintiff experienced femoral loosening of his prosthetic right hip.Plaintiff underwent right revision surgery on (b)(6) 2017.Plaintiff condition is chronic pain syndrome.

• Brand Name: UNKNOWN
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: robert rust ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 6792274
• MDR Text Key: 82617527
• Report Number: 1020279-2017-00626
• 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: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71306611
• Device Lot Number: 16DM22222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2016
• 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
• Treatment: 71332525 / 16EB00711.; 71332754 / 15FM13977.; 71335554 / 16LW11585.; 71336500 / 16LM02382.; 71343604 / 16LM01618.; 71369894 / 14DM04511 & 16FM01486.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male