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

Catalog Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 10/25/2019

Event Type  Injury  

Event Description

It was reported that the patient underwent a closed reduction due to dislocation on (b)(6) 2019.The cup was retained and the unknown ceramic head was involved.The stem was from a competitor device.

Manufacturer Narrative

The device, used for treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms the manual manipulation of the hip as well as the hip instability due to his previous anterior and posterior operative approaches cannot be ruled out as contributing factors to his acute dislocation.The dislocation is not associated with a malperformance of the implant.The patient impact beyond the closed reduction cannot be determined.No further clinical assessment is warranted at this time.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: UNKNOWN FEM HEAD MEMPHIS CERAMIC
• 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: 10269969
• MDR Text Key: 198681362
• Report Number: 1020279-2020-03178
• 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
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/19/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 06/19/2020
• Supplement Dates FDA Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention