MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOLOX DELTA HEAD 36 MM 12/14 M / +4; PROSTHSIS KNE PATELLOFEMOROTIBIAL SMI-CONSTRAIND CMNTED POLYMER/MTAL/POLYMR

Catalog Number	76539166
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed, in a dislocated head.
Event or Problem Description
It was reported that a dislocation occurred.No medical intervention was reported.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, based on the limited information provided and without the return of the device for evaluation the root cause of the reported dislocation cannot be definitively concluded.However, given the two separately reported dislocations so soon after implantation (10 days) the failure to maintain post-operative hip precautions cannot be ruled out based on the patients reportedly dislocation from seated (and/ or lying in bed) positions.The future impact to the patient cannot be determine.Should additional information become available this issue can be re-elevated.No further clinical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: BIOLOX DELTA HEAD 36 MM 12/14 M / +4
• Common Device Name: PROSTHSIS KNE PATELLOFEMOROTIBIAL SMI-CONSTRAIND CMNTED POLYMER/MTAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8167174
• Report Number: 1020279-2018-02794
• Device Sequence Number: 14113502
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2019

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: 76539166
• Device Lot Number: 18FT05323
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 11/19/2018; 11/19/2018
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 12/19/2018; 06/10/2019
• 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; Other; Required Intervention