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

Catalog Number UNKN01100500

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 05/27/2020

Event Type  Injury  

Event Description

It was reported that after the procedure, revision surgery was performed because the patient has a dissociation.The patient has experienced disassociation before this case, so the past case has resolved in another revision surgery ((b)(6) 2019).

Manufacturer Narrative

It was reported that after the procedure, revision surgery was performed because the patient has a dissociation.The patient has experienced disassociation before this case.The affected 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.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 patient information or operative reports have been provided for inclusion in this medical investigation.Therefore no medical assessment can be performed at this time.Based on this investigation, the need for corrective action is not indicated.Possible causes could include but are not limited to fit/sizing, traumatic injury, abnormal motion over time or patient medical conditions.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: UNKN FEMORAL HEAD 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: 10174941
• MDR Text Key: 195765435
• Report Number: 1020279-2020-02612
• 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: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01100500
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 11/13/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention