MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CONT RECON RING 56/52 LFT; MESH, SURGICAL, ACETABULAR, HIP, PROSTHESIS

Model Number 71337156

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

It was reported that the flap fracture of the acetabular ring, resulting in loosening of the implant.

Manufacturer Narrative

Results of investigation: it was reported that the flap of the acetabular ring fractured, resulting in loosening of the implant.The affected contour reconstruction ring, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Possible causes of device fracture could include but not limited to traumatic injury, user/procedural variance or size of device.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical records, 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: CONT RECON RING 56/52 LFT
• Type of Device: MESH, SURGICAL, ACETABULAR, HIP, PROSTHESIS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8727961
• MDR Text Key: 148980861
• Report Number: 1020279-2019-02453
• Device Sequence Number: 1
• Product Code: JDJ
• UDI-Device Identifier: 03596010308290
• UDI-Public: 03596010308290
• Combination Product (y/n): N
• PMA/PMN Number: K962541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

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 Model Number: 71337156
• Device Catalogue Number: 71337156
• Device Lot Number: 16CM04509
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2019
• Initial Date FDA Received: 06/24/2019
• Supplement Dates Manufacturer Received: 06/03/2019
• Supplement Dates FDA Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR