MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 CONST 52MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Model Number	71339152
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a revision total hip replacement on the left side, the 52mm r3 constrained liner did not work: the hip kept dislocating.The surgeon asked for another equivalent implant, which was not immediately available.As consequence, the surgery was delayed, which resulted in unnecessary prolonged anesthesia.There was not any adverse event on the patient.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).Mdr report #: mw5111878.
Additional Manufacturer Narrative
B5: event description.
Event or Problem Description
It was reported that, during a conversion from partial hip replacement to total hip replacement on the left side, the surgeon was over stressing the 52mm r3 constrained liner, which rendered it inoperable.The surgeon asked for another equivalent implant, which was not immediately available.The back-up implant was sourced from the nearest office.Although this resulted in a surgical prolongation of over 30 min, the surgeon used that time to also explant the stem.There was not any adverse event on the patient.
Additional Manufacturer Narrative
A1, a2, a3: patient information.
Additional Manufacturer Narrative
Section h3, h6: the device was not returned for evaluation and the reported event could not be confirmed.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 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.Factors that could contribute to the reported event include surgical technique used or user/procedural variance.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.H6: health effect - impact code and medical device problem code.

• Brand Name: R3 CONST 52MM
• 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: 15629222
• Report Number: 1020279-2022-04467
• Device Sequence Number: 8035310
• Product Code: KWZ
• UDI-Device Identifier: 00885556022443
• UDI-Public: 00885556022443
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K083566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/14/2022

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: 71339152
• Device Catalogue Number: 71339152
• Device Lot Number: 22AM15956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 09/22/2022; 09/22/2022; 11/10/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 11/01/2022; 11/08/2022; 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• 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
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 54 KG