MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOLOX DELTA HEAD 36 MM 12/14 M / +4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

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	08/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after thr revision surgery had been performed on (b)(6) 2021, the patient experienced an infection.This adverse event was solved by revision surgery on (b)(6) 2021, to wash out and replace the biolox delta head 36 mm 12/14 m / +4 and a competitor brand liner.Current status of patient is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a s+n head/(competitor) liner exchange/revision was performed on a mixed-manufacturer construct due to infection approximately 2.5 months post implantation.Based on information provided, a competitor liner and stem was part of the construct.Responses to the information requests had not been received as of the date of this medical assessment.Reportedly the infection was the root cause of the revision; however, the source of the reported infection remains unknown.The patient impact beyond the reported infection and subsequent revision could not be determined.No further medical assessment could be rendered at this time.Should clinically relevant documentation/ information become available, the clinical/medical task may be re-evaluated.A review of the complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.A review of the sterilization records revealed the batch was sterilized within normal parameters.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: BIOLOX DELTA HEAD 36 MM 12/14 M / +4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12329300
• Report Number: 1020279-2021-06400
• Device Sequence Number: 2733375
• 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: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 76539166
• Device Catalogue Number: 76539166
• Device Lot Number: 19ET21063
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 10/06/2021
• 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