MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID US CRMC LINER 56; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number	71338956
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthritis (1723); Failure of Implant (1924); Unequal Limb Length (4534)
Date of Event	08/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case- (b)(4).
Event or Problem Description
It was reported that, after total hip replacement had been performed on (b)(6) 2008, the patient was seen for arthritis of the opposite hip.The patient complained of things not feeling right on the surgically replaced hip.Upon further evaluation, a leg length discrepancy was determined.This adverse event was solved by performing a revision surgery on (b)(6) 2021.Patient's current health status is unknown.

• Brand Name: R3 36MM ID US CRMC LINER 56
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12476192
• Report Number: 1020279-2021-06891
• Device Sequence Number: 3349982
• Product Code: MRA
• UDI-Device Identifier: 00885556022115
• UDI-Public: 885556022115
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71338956
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 10/19/2021
• 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: Required Intervention
• Patient Age: 63 YR