MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 28 20 DEG 46-48 D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71333323
Medical Device Problem Codes	Difficult to Insert (1316); Defective Device (2588)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the reflection xlpe liner was not fitting/engaging to its corresponding reflection shell.Hcp tried everything to get it engaged by cleaning the shell, clearing soft tissues from shell.A delay of less than 30 min was reported.S&n back up was available to complete the procedure.Patient injuries were not reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The contribution of the device to the reported event could not be corroborated.A visual inspection of the returned device could not confirm the stated failure mode.The device has signs of damage from attempted use.A dimensional inspection was attempted, but the device was too damaged from the attempted insertion to obtain accurate measurements.A review of complaint history did not reveal similar events for the listed device.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 revealed this failure mode was previously identified.The anticipated risk level is still adequate.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.Assessment of historical escalated cases concluded that there are no prior actions related to this product and failure mode.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.We consider this investigation closed.

• Brand Name: REF XLPE 28 20 DEG 46-48 D
• 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: 10355738
• Report Number: 1020279-2020-03634
• Device Sequence Number: 11362533
• Product Code: JDI
• UDI-Device Identifier: 03596010455604
• UDI-Public: 03596010455604
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K002747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2021

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: 71333323
• Device Catalogue Number: 71333323
• Device Lot Number: 19GM24747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Female