MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71337654
Medical Device Problem Codes	Unstable (1667); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During hip joint replacement operation the surgeon implanted r3 cup.The surgeons were intended to insert the liner.The first liner was not inserted into r3 cup as the liner mechanism did not lock in place.The surgeons decided to replace it with another one and during its inserting (they beat it strongly into the cup) they saw that the liner crushed.It was putted out and replaced with the third liner which was easily and quickly implanted.A delay greater than 30 min was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device has signs of damage from the attempted insertion.The device was manufactured in 2019.A dimensional inspection could not confirm the stated failure mode.Features that were undamaged were found to be within specification.Other features could not be accurately measured due to damage from the attempted insertion.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.At this time, we do not have 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 improper sizing or a procedural error.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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: R3 20 DEG XLPE ACET LNR 32MM X 54MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10203472
• Report Number: 1020279-2020-02791
• Device Sequence Number: 16398848
• Product Code: JDI
• UDI-Device Identifier: 03596010598509
• UDI-Public: 03596010598509
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/14/2021

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 Model Number: 71337654
• Device Catalogue Number: 71337654
• Device Lot Number: 19AM15773
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 06/29/2020; 10/13/2020; 01/12/2021
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 07/06/2020; 10/16/2020; 01/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 75