MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 32 20 ANT +4 50-52 E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 71333434

Device Problem Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during thr procedure, the implant "popped" out of the cup while doing a range of motion.The procedure was completed without delay, using a backup from smith & nephew.No patient injury or other complications were reported at the moment.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

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.A dimensional evaluation of the returned device did not confirm the stated failure mode.The device was found to be within tolerance.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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 and potential harm was previously identified.Some potential probable causes could be but are not limited to size of the device or patient anatomy.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 32 20 ANT +4 50-52 E
• Type of Device: 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 11109300
• MDR Text Key: 224810696
• Report Number: 1020279-2021-00041
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010482778
• UDI-Public: 03596010482778
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002747
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

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
• Device Operator: Health Professional
• Device Model Number: 71333434
• Device Catalogue Number: 71333434
• Device Lot Number: 19JM12447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1