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	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	02/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tha had been performed on an unspecified date, the system luxated on (b)(6) 2022.Upon revision surgery to address this event on (b)(6) 2022, it was noticed that the r3 const 54mm liner is fractured.Current health status of patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that, after a revision tha had been performed on (b)(6) 2021, the system luxated on (b)(6) 2022.Upon revision surgery to address this event on (b)(6) 2022, it was noticed that the r3 const 54mm liner is fractured.Both the r3 shell and liner, as well as the femoral head, were explanted and replaced with competitor products.A redapt stem remains in-situ.Current health status of patient is unknown.
Additional Manufacturer Narrative
The device was not returned for evaluation but the pictures were reviewed, and the fracture device was confirmed.The clinical/medical investigation concluded that, the reported dislocations may be consistent with the fractured liner; however, with the information provided the clinical root cause of the reported fractured liner cannot be confirmed.The patient impact beyond the dislocation, revision, and expected transient post-op convalescence period cannot be determined.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 risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the instructions for use for this device revealed that cracking or fracture of implant components has been identified in possible adverse effects and may result from failure to observe the warnings and precautions that follow.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 traumatic injury or surgical technique.The contribution of the device to the reported event could be corroborated, since it was broke, therefore it could function properly anymore.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 54MM
• 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: 13794788
• Report Number: 1020279-2022-01219
• Device Sequence Number: 3812851
• Product Code: KWZ
• UDI-Device Identifier: 00885556020227
• UDI-Public: 00885556020227
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 04/27/2022

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 Expiration Date: 09/11/2017
• Device Model Number: 71339154
• Device Catalogue Number: 71339154
• Device Lot Number: 17JM06260
• 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: 02/25/2022
• Supplement Date Received by Manufacturer: 03/17/2022; 04/13/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 03/23/2022; 04/27/2022
• 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: 71331854 / R3 0 HOLE ACET SHELL 54MM; 71342200 / OXINIUM FEM HD 12/14 22 MM +0 /
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female