MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71337652
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tha had been performed on (b)(6) 2020, the patient dislocated the prosthesis for not correctly impacting the polyethylene.The device has failed because the insert was not impacted correctly and it was coming out of the shell, rubbing against the femoral head.The r3 20 deg xlpe acet lnr 32mm was replaced.The patient outcome is unknown.
Additional Manufacturer Narrative
The associated device was returned and evaluated (no destructive testing was performed).The contribution of the device to the reported event could not be corroborated.The lab analysis concluded that the oxinium head shows damage to the oxide region of the head.The liner shows some damage and deformation.These findings are consistent with the reported information from the complaint.No material or manufacturing deviations were found.A review of complaint history did not reveal similar events for the listed device.The clinical/medical evaluation concluded that per complaint details, we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.The requested clinical information, operative report or radio graphs were not provided.Therefore, based on the information provided (¿the device has failed because the insert was not impacted correctly and it comes out of the shell, rubbing against the femoral head.¿), the r3 20 deg xlpe acet lnr 32mm x 52mm was replaced.Since it was reported the patient is doing ¿ok¿ no further clinical/medical assessment is warranted at this time.Should any additional medical information be provided, this complaint would be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.Internal complaint reference number: case-2020-00035100-1 section h8 was corrected.

• Brand Name: R3 20 DEG XLPE ACET LNR 32MM X 52MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 11156128
• Report Number: 1020279-2021-00289
• Device Sequence Number: 4132466
• Product Code: JDI
• UDI-Device Identifier: 03596010598493
• UDI-Public: 03596010598493
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2022

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
• Operator of Device: Health Professional
• Device Model Number: 71337652
• Device Catalogue Number: 71337652
• Device Lot Number: 19JM05544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown