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

Catalog Number UNKNOWN

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

Patient Problem Joint Dislocation (2374)

Event Date 12/14/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, surgeon booked a patient for a revision surgery on 17 december of the acetabulum, because the patient keeps dislocating.It is unknown if there were further complications.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, no relevant supporting clinical information has been provided for inclusion in this medical investigation.According to the report, the surgeon booked the patient for a revision.However, per subsequent e-mail, ¿this case has been postponed with no new surgery date due to covid-19¿.Therefore, the impact to the patient beyond that which has already been reported cannot be determined.Should any additional medical information be provided, this complaint will be re-assessed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.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: UNKNOWN MEMPHIS RECON HIP INSTR
• 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: 11124906
• MDR Text Key: 225326506
• Report Number: 1020279-2021-00149
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 09/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• 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
• Date Manufacturer Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1