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

Model Number	71339156
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after thr procedure had been performed on an unknown date, the patient experienced dislocation.This adverse event was addressed by revision surgery on (b)(6) 2022 to exchange the r3 3 hole acet shell 56mm, r3 const 56mm and cocr 12/14 fem head 22 + 8.Current health status of patient is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, without patient specific documentation, the explanted device, and/or adequate materials to fully evaluate the root cause of the complaint, the patient impact beyond that which was reported (dislocation and subsequent revision) could not be determined.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for total hip systems revealed that dislocation has been identified in warnings and precautions as a result of improper neck selection, positioning, looseness of acetabular or femoral components, extraneous bone, penetration of the femoral prosthesis through the shaft of the femur, fracture of the acetabulum, intrapelvic protrusion of acetabular component, femoral impingement, periarticular calcification, and/or excessive reaming.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.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, 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.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: 14467035
• Report Number: 1020279-2022-02525
• Device Sequence Number: 11904453
• 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 Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2022

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?: No
• Device Model Number: 71339156
• Device Catalogue Number: 71339156
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 05/21/2022
• Supplement Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown