MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM -3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71343603
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to unknown reasons.36-3 ox head was removed.It was replaced with competitive product.Unable to read lot numbers.No more information provided yet.
Additional Manufacturer Narrative
The associated complaint device was not returned.The medical investigation concluded that no clinically relevant supporting documentation was provided and the patient's current condition is unknown.Therefore, a thorough medical investigation could not be performed.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: OXINIUM FEM HD 12/14 36 MM -3
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8787552
• Report Number: 1020279-2019-02662
• Device Sequence Number: 1998784
• Product Code: JDI
• UDI-Device Identifier: 03596010000675
• UDI-Public: 03596010000675
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K022958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2019

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: 71343603
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 07/14/2019
• Supplement Report FDA Received Date: 10/09/2019
• 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