MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 XLPE ACET LNR; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71339550
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed on (b)(6) 2019 due to ongoing pain.Head, cup and liner were removed; new devices were inserted.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to on going pain.Head, cup and liner were removed.The associated cobalt chrome femoral head, acetabular liner and r3 3-hole acetabular shell, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the head and the shell did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.Liner information was not correctly provided.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.A medical analysis noted that based on the limited information provided and diagnostic images, the root cause of the reported ongoing pain cannot be determined but if it was due to the stated ¿insufficient offset¿ as noted by the surgeon then this would be an issue due to the device selection and procedure planning.The impact to the patient beyond the revision cannot be concluded at this time.Based on this investigation, the need for corrective action is not indicated.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.

• Brand Name: R3 XLPE ACET LNR
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8491860
• Report Number: 1020279-2019-01450
• Device Sequence Number: 16501942
• Product Code: MBL
• UDI-Device Identifier: 03596010598806
• UDI-Public: 03596010598806
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020

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 Model Number: 71339550
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 02/27/2020
• 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 Weight: 85