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

Catalog Number UNKN01100401

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

Patient Problem Muscle/Tendon Damage (4532)

Event Date 03/17/2021

Event Type  Injury  

Event Description

It was reported that on literature review ¿short-term effect of total hip arthroplasty via direct anterior approach with general prosthesis.Author: peng zhaohua,zhao zujie,yang bin,yang jun¿ 4 patients presented injury of lateral cutaneous nerve while using unkn reflection metal cup impl, 1 patient presented blunt cutting injury of hip tensor fasciae latae while using unkn reflection metal cup impl, 1 patient presented intraoperative fracture of greater trochanter while using unkn synergy hip imp 1 patient presented intraoperative cleavage fracture of calcar femorale while using unkn synergy hip imp, 1 patient presented posterior dislocation of the hip while using unkn fem head impl memphis and 1 patient presented posterior dislocation of the hip while using unkn reflection liner.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, there was a blunt cutting injury of hip tensor fasciae latae.Without the requested clinical information/documentation, further assessment of the reported events could not be provided and the root cause beyond those reported in the article could not be concluded.The patient impact beyond the reported events could not be determined.No further medical assessment could be rendered at this time.Should additional clinically relevant documentation become available the medical investigation task may be re-evaluated.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 REFLECTION 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: 11648778
• MDR Text Key: 244879418
• Report Number: 1020279-2021-02937
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01100401
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention