MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 CONST 56MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Model Number	71339156
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Discomfort (2330)
Date of Event	03/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, after total hip replacement was performed on (b)(6) 2021, the patient experienced discomfort and a grinding feeling in the hip joint.Upon investigation, it was discovered that the r3 constrained acetabular liner 56mm had broken.The plastic clip that holds the small head in had been damaged and was no longer keeping the head inside the liner.It was twisted and floating around inside the joint, with the small wire completely disengaged.This adverse event was treated with a revision surgery on (b)(6) 2022.This was the patient¿s second revision (the first one due to dislocation conducted on (b)(6) 2021 due to dislocation), for which all thr components were revised and the angle of the acetabular cup and the femoral neck was changed.Current patient's health status is unknown.
Additional Manufacturer Narrative
Section h3, h6: the device was not returned for evaluation but the pictures were reviewed, and they confirm that the inner liner and ball head rotated off the femoral head and the head is not centered within the acetabular cup.The clinical/medical investigation concluded that, the provided x-rays were reviewed and support the complaint description of a constrained liner with the inner liner and ball head rotated off the femoral head and the head is not centered within the acetabular cup.However, smith and nephew has not received the device/ adequate materials to fully evaluate the root cause of the damaged acetabular liner, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for the r3¿ constrained liner acetabular system revealed that fracture of the implant has been identified as a possible adverse effect.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to trauma, strenuous activity, improper alignment or duration of service.The contribution of the device to the reported event could be corroborated since the liner is rotated and the head is not centered within the acetabular cup, requiring a second revision surgery.Based on this investigation, the need for corrective action is not indicated.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.We consider this investigation closed.

• Brand Name: R3 CONST 56MM
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13876743
• Report Number: 1020279-2022-01323
• Device Sequence Number: 20006505
• Product Code: KWZ
• UDI-Device Identifier: 00885556020470
• UDI-Public: 00885556020470
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2022

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: 71339156
• Device Catalogue Number: 71339156
• Device Lot Number: 19FM05927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OXINIUM FEM HD 12/14 22 MM +4-21CM11258.; POLARSTEM COLLAR LAT. TI/HA 4-B1900678.; R3 3 HOLE HA CTD ACET SHELL 56MM-21DM08355.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown