MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF INTERFIT THRD HOLE COVER; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71330001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Physical Asymmetry (4573)
Date of Event	01/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, a revision surgery was performed due to wear.The patient experienced falling.Reflection xlpe acetabular liner ((b)(4)), oxinium head 10/12 28mm +5 ext ((b)(4)) and ref interfit thrd hole cover ((b)(4)) 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 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 has a few scratches along its surface which were likely from use or extraction.The device shows signs of prolonged use.A functional evaluation of the returned device did not confirm the stated failure mode.The device would function as intended.The clinical/medical evaluation concluded that per complaint details, approximately 7.5 years post implantation the patient underwent a revision of the head, liner and hole cover ¿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 limited information provided, the reported wear and ¿experienced falling¿ could not be ruled out as a potential contributing factors 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 revision of the hole cover is suspect.The patient impact beyond the reported wear and head/liner/hole cover revisions could not be determined.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information and/or product evaluation findings 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.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.We consider this investigation closed.

• Brand Name: REF INTERFIT THRD HOLE COVER
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11612103
• Report Number: 1020279-2021-02642
• Device Sequence Number: 3496562
• Product Code: MBL
• UDI-Device Identifier: 03596010196590
• UDI-Public: 03596010196590
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K960094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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 Model Number: 71330001
• Device Catalogue Number: 71330001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Initial Date Received by Manufacturer: 03/07/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 04/04/2021
• Supplement Report FDA Received Date: 09/16/2021
• 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; Other; Required Intervention