MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 56MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Model Number	71335756
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the procedure thr that the r3 liner would not seat in the shell.The procedure was completed without delay and with a backup from smith & nephew.No patient injury or other complications were reported.
Event or Problem Description
It was reported during the procedure thr that the r3 liner would not seat in the shell.The procedure was completed without delay and backup from smith & nephew was available to finish the surgery.The surgeon did not blame the device and was satisfied with the surgical outcome.No patient injury or other complications were reported.
Additional Manufacturer Narrative
Updated b5: description of problem.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection was completed but could not confirm the state failure.There are gouges and minor damage to the liner.The liner exhibits deep scratches/deformation on the id and id rim.A dimensional analysis could not be completed due to damage to the liner from attempting to insert it into the shell.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: R3 20 DEG XLPE ACET LNR 36MM X 56MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10708441
• Report Number: 1020279-2020-05585
• Device Sequence Number: 3733079
• Product Code: JDH
• UDI-Device Identifier: 03596010598356
• UDI-Public: 03596010598356
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2021

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: 71335756
• Device Catalogue Number: 71335756
• Device Lot Number: 20AM23159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 09/23/2020; 07/02/2021
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 11/16/2020; 07/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1