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

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	10/10/2009
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had low haemoglobin and low blood pressure.Patient received 2 units of blood transfusion.
Additional Manufacturer Narrative
It was reported from a clinical study that patient had low haemoglobin and low blood pressure.The affected r3 acetabular liner, cobalth chrome femoral head, anthology standard offset stem and r3 acetabular shell, used in treatment, were not returned for evaluation as they remained implanted.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.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 incident could not be corroborated.No relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.It was communicated that the failure was caused by the study procedure.No patient complications reported as it was presumed that this was resolved with 2 units of blood transfusion.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.

• Brand Name: COCR 12/14 FEM HD 28 -3
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9670982
• Report Number: 1020279-2020-00479
• Device Sequence Number: 354008
• Product Code: LPH
• UDI-Device Identifier: 03596010194121
• UDI-Public: 03596010194121
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,study,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2020

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 Expiration Date: 07/25/2018
• Device Model Number: 71302803
• Device Catalogue Number: 71302803
• Device Lot Number: 08GM19293
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 06/02/2020
• 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