MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 CONST 52MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Model Number	71339152
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed on (b)(6) 2018 due to dislocation and instability of the redapt cemented xlpe liner.This implant was replaced with a r3 constrained liner.On (b)(6) 2018, the r3 constrained liner failed and was replaced with biomet dual mobility liner.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.He clinical/medical investigation concluded that this clinical study case (redapt fully porous shell and xlpe liner) reports that the patient underwent a revision due to a failed r3 constrained liner.To date, the requested surgical records and x-rays have not been provided to fully evaluate the root cause of the reported event.Without clinically relevant patient-specific supporting documentation a thorough medical investigation cannot be performed.No further medical assessment is warranted at this time.Should clinically relevant documentation/ information become available, the clinical/medical task may be re-evaluated.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Possible causes could include but not limited to traumatic injury, surgical technique or size of device.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: R3 CONST 52MM
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10719280
• Report Number: 1020279-2020-05644
• Device Sequence Number: 14327944
• Product Code: KWZ
• UDI-Device Identifier: 00885556022443
• UDI-Public: 00885556022443
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K083566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71339152
• Device Catalogue Number: 71339152
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 06/28/2021
• 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: Hospitalization; Required Intervention