MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOLOX DELTA HEAD 36 MM 12/14 S / +0; PROSTHESIS,HIP,SEMICONSTRNED,MTAL/CRMIC/PLYMER,CEMNTD,UNCEMENT

Catalog Number	76539165
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to infection on the tissue and hip joint.Delay of less than 30min reported.
Event or Problem Description
It was reported that a revision surgery was performed due to infection on the tissue and hip joint.Delay of less than 30 min reported.
Additional Manufacturer Narrative
The affected redapt femoral standard offset sleeveless stem and biolox delta head were not returned for evaluation.As the devices were not made available for investigation, the failure mode cannot be determined or confirmed.However, batch number was provided for both devices.Thus, a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.Our investigation including a review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode.There is no information that would suggest the implanted devices failed to meet specifications.A clinical evaluation noted that no clinical relevant supporting documents were provided to conduct a thorough medical assessment of the reported infection.Without the lab results, surgical findings, medical documents, x-rays, or explants for analysis the root cause of the reported infection cannot be definitively concluded; however, based on the report of multiple surgeries and that the ¿operative site has become infected¿, the reported ongoing infection was the cause for revision and infections as described are not usually a result of product failures or sterility issues of the device but are procedure related infections or hematogenously spread.The future impact to the patient cannot be determined, although continued infection is likely based on the (stage 1/revision) intraoperative findings of ¿frank infection noted in all tissue layers down to and including the hip joint.¿ no further clinical assessment is warranted at this time.Without the return of the actual product involved, our investigation of this report is inconclusive at this time.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: BIOLOX DELTA HEAD 36 MM 12/14 S / +0
• Common Device Name: PROSTHESIS,HIP,SEMICONSTRNED,MTAL/CRMIC/PLYMER,CEMNTD,UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8184673
• Report Number: 1020279-2018-02853
• Device Sequence Number: 19207976
• Product Code: LZO
• UDI-Device Identifier: 00885556579343
• UDI-Public: 00885556579343
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2019

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: 76539165
• Device Lot Number: 18FT04860
• Initial Date Received by Manufacturer: 12/01/2018
• Supplement Date Received by Manufacturer: 12/01/2018; 12/01/2018
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 12/31/2018; 03/05/2019
• 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