MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71336458
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a surgery was schedule for a patient after a pet scan was performed.Clinical analysis indicated an infection was present.The decision was made to remove the cup and liner as well as the femoral head.The new implants were from a competitor, however a s&n femoral head (36mm +12) was implanted.Patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
It was reported that a surgery was scheduled for a patient after a pet scan was performed.Clinical analysis indicated an infection was present.The decision was made to remove the cup and liner as well as the femoral head.The affected r3 three hole shell, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of manufacturing records 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.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.The device was sterilized according to the device history record review.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.Based on this investigation, the need for corrective action is not indicated.The device was manufactured in 2002, which suggests it has been implanted for some time.The cause of infection might include but not limited to patient medical conditions.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we 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: REF THREE HOLE SHELL 58MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10439571
• Report Number: 1020279-2020-04149
• Device Sequence Number: 11417594
• Product Code: MBL
• UDI-Device Identifier: 03596010454386
• UDI-Public: 03596010454386
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K960094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

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: 12/30/2015
• Device Model Number: 71336458
• Device Catalogue Number: 71336458
• Device Lot Number: 02KM00423
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 11/10/2020
• 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