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

Catalog Number	76539160
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient presented a dislocation of left thr when transferring from bed to chair due to loose femoral component.Revision surgery was required.
Event or Problem Description
It was reported that patient presented a dislocation of left thr when transferring from bed to chair due to loose femoral component.Revision surgery was required.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A clinical analysis concluded that it was reported this patient presented with a dislocation of left thr when transferring from bed to chair.Neither the explant nor clinical information will be provided for inclusion in this investigation.Based on the information provided, the dislocation of the lthr occurred while the patient transferred from bed to chair.The pre-operative ct and ap x-rays confirms dislocated lthr.However, the future impact to the patient beyond the revision cannot be concluded.No further clinical medical assessment is warranted at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: BIOLOX DELTA HEAD 32 MM 12/14 S / +0
• Common Device Name: PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/POLY,CEMENTED OR NON-POROUS,UNCEME
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7265858
• Report Number: 1020279-2018-00163
• Device Sequence Number: 13909233
• Product Code: LZO
• UDI-Device Identifier: 03596010566928
• UDI-Public: 03596010566928
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2018

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: 76539160
• Device Lot Number: 14AT38670
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2018
• Supplement Date Received by Manufacturer: 01/17/2018; 01/17/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 02/13/2018; 05/10/2018
• 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
• Patient Age: 78 YR