MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HEAD 36MM +0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71303600
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to infection.The liner and head were removed.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to infection.The liner and head were removed.The affected r3 acetabular liner and cobalt chrome femoral head, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.The devices were sterilized according to sterilization release documentation from quality control.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported event could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.Infection, a potential complication associated with any surgery, can occur and possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.

• Brand Name: COCR 12/14 FEM HEAD 36MM +0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9315172
• Report Number: 1020279-2019-03997
• Device Sequence Number: 16260403
• Product Code: LPH
• UDI-Device Identifier: 03596010479983
• UDI-Public: 03596010479983
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

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: 71303600
• Device Catalogue Number: 71303600
• Device Lot Number: 19FM22159
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 03/19/2020
• 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