MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOLOX DELTA HEAD 32 MM 12/14 S / +0; PROSTHE, HIP, SEMI-CONS, METAL/CERAMIC/POLY, CEMEN OR NON-POROUS, UNCEMEN

Model Number	76539160
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was participating on the "(b)(6) study" and underwent a revision surgery of the head, shell and liner due to unknown reasons.
Additional Manufacturer Narrative
Reviewing the information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The information states that this incident was already reported under the report number 1020279-2019-03659, 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: BIOLOX DELTA HEAD 32 MM 12/14 S / +0
• Common Device Name: PROSTHE, HIP, SEMI-CONS, METAL/CERAMIC/POLY, CEMEN OR NON-POROUS, UNCEMEN
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9375579
• Report Number: 1020279-2019-04154
• Device Sequence Number: 2060789
• Product Code: LZO
• UDI-Device Identifier: 03596010566928
• UDI-Public: 03596010566928
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2020

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: 05/28/2024
• Device Model Number: 76539160
• Device Catalogue Number: 76539160
• Device Lot Number: 14ET42301
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 01/14/2020; 01/14/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 01/15/2020; 02/25/2020
• 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