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
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Case- (b)(4).
Event or Problem Description
It was reported that, during a thr procedure, using a reflection xlpe the implant popped out of cup when going through range of motion.Another liner was used.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were 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 device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints 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 have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.The potential probable causes for this event could include but not limited to a user or procedural error.Based on this investigation, the need for corrective action is not indicated.Without the actual products involved and/or device information, our investigation cannot proceed.If these devices or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: REF XLPE 32 20 ANT +4 50-52 E
• 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: 10991121
• Report Number: 1020279-2020-07374
• Device Sequence Number: 19702445
• Product Code: JDI
• UDI-Device Identifier: 03596010482778
• UDI-Public: 03596010482778
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K002747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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: 71333434
• Device Catalogue Number: 71333434
• Device Lot Number: 19JM12447
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 05/15/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1