MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF ALL POLY 32ID 49OD XLPE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71358034
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a hip replacement surgery had been performed on (b)(6) 2020, the patient experienced an unspecified infection.This adverse event was solved by performing a two revision surgeries, the latest on (b)(6) 2021.Current health status of patient in unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the second-stage revision was performed approximately 6-months post first-stage revision due to an unspecified infection.Per correspondence, the surgeon did not fault the devices as they "were intended to be removed when implanted¿.It was communicated that an attempt was being made to recover the stem, but it was ¿likely thrown out¿ and no further information was available for inclusion in the medical investigation.Reportedly, the clinical root cause of the 2-stage revision was an infection; however, the root cause of the infection could not be assessed.The patient impact beyond the reported infection and subsequent 2-stage revision could not be determined.No further medical assessment could be rendered at this time.Should clinically relevant documentation become available in the future, this case may be re-opened/re-assessed.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.A review of the sterilization records revealed the batch was sterilized within normal parameters.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: REF ALL POLY 32ID 49OD XLPE
• 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: 12046418
• Report Number: 1020279-2021-05351
• Device Sequence Number: 3348006
• Product Code: JDI
• UDI-Device Identifier: 03596010474247
• UDI-Public: 03596010474247
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K002747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71358034
• Device Catalogue Number: 71358034
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 08/21/2021
• 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