MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 CONST 58MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Model Number	71339158
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a thr revision surgery, an r3 const 58mm did not engage with the redapt shell, but the femoral head did engage, then another r3 const 58mm engaged with the shell, but not with the femoral head.Surgery was performed with a delay greater than 30 minutes, using a s+n back-up device.Patient was not harmed as consequence of this problem.
Event or Problem Description
It was reported that, during a thr revision surgery, an r3 const 58mm did not engage with the redapt shell, but the femoral head did engage, then another r3 const 58mm engaged with the shell, but not with the femoral head.Surgery was performed with a delay greater than 30 minutes, using a s+n back-up device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
Section h3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation including the operative report has not been provided; therefore, there were no clinical factors found which would have definitively contributed to the event.The patient impact beyond the reported events and the subsequent revision cannot be determined.However, it has been communicated ¿patient was not harmed as consequence of this problem.¿ the procedure was reportedly completed with a delay greater than 30 minutes using a smith and nephew backup device.No patient injury has been alleged.Therefore, no further clinical/medical assessment is warranted.Should additional clinically relevant information/documentation become available, the clinical/medical task may be re-opened for further evaluation.A review of the production order 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 historical review concluded that there are no prior actions related to this products and event.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.Factors that could contribute to the reported event include surgical technique used, size selected or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Should the devices 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.B5: describe event or problem.

• Brand Name: R3 CONST 58MM
• 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: 16126289
• Report Number: 1020279-2023-00053
• Device Sequence Number: 6547147
• Product Code: KWZ
• UDI-Device Identifier: 00885556020876
• UDI-Public: 00885556020876
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K083566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71339158
• Device Catalogue Number: 71339158
• Device Lot Number: 20JM05111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2022
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown