MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 28 0 DEG 46-48 SZ D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71333373
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, a revision surgery was performed due to wear.The patient experienced falling.Reflection xlpe acetabular liner and unknown femoral head devices were explanted.The procedure was completed without delay using a smith & nephew back-up devices.No other complications were reported.
Additional Manufacturer Narrative
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 medical investigation was conducted and confirms per complaint details, approximately 7.5 years post implantation the patient underwent a revision of the head and liner ¿due to wear¿.Reportedly, the patient ¿experienced falling¿ and the ¿surgeon did not reject possibility of defect¿.However, it was communicated that the requested op notes and x-rays were not available for inclusion in the medical investigation.Based on the information provided, the reported wear could not be ruled out as a potential contributing factor to the reported events, although the definitive root cause could not be concluded.No supporting documentation was provided; therefore, the ¿possibility of defect¿ could not be confirmed or concluded.The patient impact beyond the reported wear and head/liner revision could not be determined.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Wear potential causes could include but are not limited to friction, joint tightness or lifetime of device.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.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.The device does appear to be worn from prolonged use.There are several indentations and scratches along the outer surface.The outer edge and locking detail appears to be naturally worn as well.The clinical/medical evaluation concluded that per complaint details, approximately 7.5 years post implantation the patient underwent a revision of the head and liner ¿due to wear¿.Reportedly, the patient ¿experienced falling¿ and the ¿surgeon did not reject possibility of defect¿.However, it was communicated that the requested op notes and x-rays were not available for inclusion in the medical investigation.Based on the information provided, the reported wear could not be ruled out as a potential contributing factor to the reported events, although the definitive root cause could not be concluded.No supporting documentation was provided; therefore, the ¿possibility of defect¿ could not be confirmed or concluded.The patient impact beyond the reported wear and head/liner revision could not be determined.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.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 and instructions for use documents revealed this failure mode and potential harm was previously identified.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.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.

• Brand Name: REF XLPE 28 0 DEG 46-48 SZ D
• 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: 11275895
• Report Number: 1020279-2021-00902
• Device Sequence Number: 14328227
• Product Code: JDI
• UDI-Device Identifier: 03596010455857
• UDI-Public: 03596010455857
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/06/2022
• Device Model Number: 71333373
• Device Catalogue Number: 71333373
• Device Lot Number: 12FM03867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 03/04/2021; 10/23/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 03/05/2021; 10/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention