MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 28MM X 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71337546
Medical Device Problem Codes	Fitting Problem (2183); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a thr, a 0 degrees xlpe acet lnr 28mm x 46mm would not seat into cup.Another liner of the same item number was opened and it seated perfectly.There was no significant delay and the procedure was finished using a smith & nephew back up.Patient was not harmed.
Additional Manufacturer Narrative
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 0 DEG XLPE ACET LNR 28MM X 46MM
• 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: 11826946
• Report Number: 1020279-2021-04339
• Device Sequence Number: 19716594
• Product Code: JDI
• UDI-Device Identifier: 03596010598455
• UDI-Public: 03596010598455
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 71337546
• Device Catalogue Number: 71337546
• Device Lot Number: 20AM04996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 07/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1