MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HD 32 + 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71303200
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to metallosis.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that revision surgery was performed due to the shell, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: COCR 12/14 FEM HD 32 + 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: 8334092
• Report Number: 1020279-2019-00543
• Device Sequence Number: 2321649
• Product Code: LPH
• UDI-Device Identifier: 03596010194176
• UDI-Public: 03596010194176
• 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: 2018
• 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): 02/13/2019

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: 71303200
• Device Lot Number: 18EM03387A
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 02/13/2019
• 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