MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOLOX DELTA HEAD 36 MM 12/14 M / +4; PROSTHESISHIPSEMICONSTRAINDMTALCERAMICPOLYMERCMNTORNONPOROUSUNCMNTD

Model Number	76539166
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed and an infection was confirmed.Head was removed.An antibiotic spacer was used.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to pain, stem subsidence and movement.The affected anthology offset stem, biolox delta head and r3 delta ceramic liner, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.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 adverse event could not be corroborated.A medical analysis noted that three undated x-rays were provided for review but did not indicate a reason for the stem subsidence.No other additional relevant information has been provided.Without the return of the actual product involved, our investigation of this report is inconclusive.Some potential causes of the reported event could include but are not limited to traumatic injury, patient anatomy or patient non-compliance.

• Brand Name: BIOLOX DELTA HEAD 36 MM 12/14 M / +4
• Common Device Name: PROSTHESISHIPSEMICONSTRAINDMTALCERAMICPOLYMERCMNTORNONPOROUSUNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9636216
• Report Number: 1020279-2020-00401
• Device Sequence Number: 379798
• Product Code: LZO
• UDI-Device Identifier: 03596010566966
• UDI-Public: 03596010566966
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2020

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 Model Number: 76539166
• Device Catalogue Number: 76539166
• Device Lot Number: 17CT83878
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 05/08/2020
• Patient Sequence Number: 1