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

Model Number	71337156
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the flap fracture of the acetabular ring, resulting in loosening of the implant.
Additional 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
• Common Device Name: MESH, SURGICAL, ACETABULAR, HIP, PROSTHESIS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8727961
• Report Number: 1020279-2019-02453
• Device Sequence Number: 2220972
• Product Code: JDJ
• UDI-Device Identifier: 03596010308290
• UDI-Public: 03596010308290
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K962541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 03/05/2026
• Device Model Number: 71337156
• Device Catalogue Number: 71337156
• Device Lot Number: 16CM04509
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR