MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HEAD 36MM +4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71303604
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after total hip arthroplasty had been performed on (b)(6) 2021, the patient experienced an infection.This adverse event was solved by a revision surgery on (b)(6) 2021, where the 20 degree xlpe acetabular liner 36mm inner diameter x outer diameter 52mm ((b)(4)) and the cobalt chrome 12/14 taper femoral head 36mm +4 ((b)(4)) were replaced.Current health status of patient is 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, a revision with a ¿liner and head exchange with washout due to infection¿ was performed approximately 1-month post implantation.It was communicated that the requested clinical documentation is not available for inclusion in the medical investigation due to lack of consent.The clinical root cause was reportedly infection; however, the root cause of the infection remains unknown.The patient impact beyond the reported infection and subsequent early 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 review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.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.

• Brand Name: COCR 12/14 FEM HEAD 36MM +4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12053906
• Report Number: 1020279-2021-05400
• Device Sequence Number: 3324847
• Product Code: LPH
• UDI-Device Identifier: 03596010479990
• UDI-Public: 03596010479990
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K022902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

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: 71303604
• Device Catalogue Number: 71303604
• Device Lot Number: 19MM16687
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 08/19/2021
• 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