MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 CONST 54MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Model Number	71339154
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tha had been performed on (b)(6) 2021, the patient experienced a dislocation while standing and pivoted.A revision surgery was conducted on (b)(6) 2021 to exchange the oxinium femoral head 12/14 22 mm +0 (case (b)(4)) and the r3 const 54mm (case (b)(4)).Patient outcome is unknown.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device does not confirm the stated failure mode.The device has deformation along the base which shows signs of impingement with the neck of the stem.There is also gouging along the locking detail likely from extraction.A dimensional inspection was attempted, but the device was too damaged to obtain accurate readings.The clinical/medical evaluation concluded that after three requests no relevant clinical information has been provided for inclusion in this medical investigation.Therefore, a thorough medical investigation cannot be rendered nor can a root cause of the reported dislocation be determined.Based on the information provided, a revision was performed, and the surgeon exchanged the patient¿s oxinium femoral head 12/14 22 mm +0 (case-2021-00061594-1) and the r3 const 54mm (case-2021-00061594-2).Since it was reported, the patient¿s current health status is healthy, no further clinical/medical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have 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, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should 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.We consider this investigation closed.

• Brand Name: R3 CONST 54MM
• 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: 12112154
• Report Number: 1020279-2021-05650
• Device Sequence Number: 14396643
• Product Code: KWZ
• UDI-Device Identifier: 00885556020227
• UDI-Public: 00885556020227
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K083566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2021

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 Model Number: 71339154
• Device Catalogue Number: 71339154
• Device Lot Number: 20GM13959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 08/18/2021
• 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