MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 36 20 DEG 62-64 H; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71333347
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the reflection xlpe liner did not lock in the shell.The procedure was completed using a s+n backup device.A surgical delay of 30 min or less was reported.No harm to the patient was reported.
Additional Manufacturer Narrative
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: REF XLPE 36 20 DEG 62-64 H
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11112088
• Report Number: 1020279-2021-00052
• Device Sequence Number: 19731995
• Product Code: LPH
• UDI-Device Identifier: 03596010479778
• UDI-Public: 03596010479778
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K022902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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: 71333347
• Device Catalogue Number: 71333347
• Device Lot Number: 19DM21688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Initial Date Received by Manufacturer: 12/13/2020
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1