MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HEAD 28 -3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71302803
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
A revision surgery was performed on july 2 due to dislocated acetabular component.Cocr head removed as part of that extraction of dislocated devices.It was implanted redapt modular shell with locking screws and constrained liner and ox 22 +0 head.Patient still in hospital.Seemed quite unwell, with blood transfusion running prior to case start.The adverse event happened not due to faulty s+n product.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to dislocated acetabular component.Cocr head removed as part of that extraction of dislocated devices.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of manufacturing records did not reveal any deviation from the standard manufacturing processes.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.No medical documents were received for investigation, therefore, no medical assessment can be performed at this time.Some potential causes of the reported event could include but are not limited to traumatic injury, patient anatomy, surgical technique or limited range of motion.It was communicated that the patient is still in the hospital.The adverse event was not due to faulty sn product.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: COCR 12/14 FEM HEAD 28 -3
• 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: 10324898
• Report Number: 1020279-2020-03526
• Device Sequence Number: 13721481
• Product Code: LPH
• UDI-Device Identifier: 03596010194121
• UDI-Public: 03596010194121
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

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: 08/14/2022
• Device Model Number: 71302803
• Device Catalogue Number: 71302803
• Device Lot Number: 12HM09810
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 02/04/2021
• 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