MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOLOX DELTA HEAD 36 MM 12/14 S / +0; PROSTHESIS, HIP, SEMI-CONSTRAIN, METAL/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMNT

Model Number	76539165
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient suffered from dislocation.Surgeon replaced the ceramic head with an oxinium 28mm and replace the existing pinnacle gription cup with a capture cup.
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, the root cause of the reported dislocation and subsequent revision were noted as ¿dislocation after sitting on a low seat¿ and the surgeons¿ intent to replace the femoral head and cup relative to the patient¿s tendency to fall.It cannot be concluded that the dislocation and revision were associated with a malperformance of the implant.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.No further clinical assessment is warranted at this time.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.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 not limited to traumatic injury, patient anatomy or abnormal loading of limb.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 S / +0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAIN, METAL/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMNT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10754837
• Report Number: 1020279-2020-05928
• Device Sequence Number: 14366781
• Product Code: LZO
• UDI-Device Identifier: 03596010566959
• UDI-Public: 03596010566959
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 76539165
• Device Catalogue Number: 76539165
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 09/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN INSERT; UNKNOWN INSERT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention