MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HD 22 + 12; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71302212
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Dislocation (2374)
Date of Event	07/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to dislocation / infection.Liner and head were exchanged.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to dislocation /infection.The associated cobalt chrome femoral head, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device was sterilized according to sterilization release documentation from quality control.A relationship, if any, between the device and the reported incident could not be corroborated.A complaint history review found related failures; this failure mode will be trended by post market surveillance to assess for any necessary corrective actions.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Per rmf, possible causes of dislocation/infection could include but not limited to patient anatomy or patient healing issue.Without the return of the actual product involved and no patient medical records available, no root cause can be determined.It was reported that the surgeon doesn¿t blame the implant.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: COCR 12/14 FEM HD 22 + 12
• 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: 8892470
• Report Number: 1020279-2019-03047
• Device Sequence Number: 1642570
• Product Code: LPH
• UDI-Device Identifier: 03596010194060
• UDI-Public: 03596010194060
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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 Catalogue Number: 71302212
• Device Lot Number: 16GM00716
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 01/17/2020
• 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