MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN ORTHOPAEDIC RECONSTRUCTION DEV; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number UNKN01000000

Device Problem Malposition of Device (2616)

Patient Problems Perforation (2001); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2021

Event Type  Injury  

Manufacturer Narrative

Case: (b)(4).

Event Description

Us legal mdl: it was reported that after a failed tha performed on (b)(6) 2020 (covered under case: (b)(4)), it was reported that, 3 screws were placed through the acetabular component without verification of landmarks or appropriate sizing of screws.Some hours after the primary surgery, a pelvic ct was performed, and findings confirmed that the screws of the cup extended into the soft tissue of the pelvis.The plaintiff was discharged that same day with recommendations for a revision.The revision surgery was performed on (b)(6) 2021 to treat this failed tha.The patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

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, the extension of the screws through the acetabular component and into the soft tissue of the pelvis, and subsequent revision are a result of the reported screw placement ¿without verification of landmarks or appropriate sizing of the screws.¿ it cannot be concluded that the reported events were associated with a malperformance of the implant.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to procedural/user error, surgical complication.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 ORTHOPAEDIC RECONSTRUCTION DEV
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11823123
• MDR Text Key: 250588192
• Report Number: 1020279-2021-04320
• Device Sequence Number: 1
• Product Code: NXT
• 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: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01000000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKN FEMORAL HEAD IMPL; UNKN ORTHOPAEDIC RECONSTRUCTION DEV; UNKN FEMORAL HEAD IMPL; UNKN ORTHOPAEDIC RECONSTRUCTION DEV
• Patient Outcome(s): Required Intervention