MAUDE Adverse Event Report: ORTHO DEVELOPMENT PIVOT; BIPOLAR FEMORAL HEAD

Model Number 133-2249

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hip Fracture (2349)

Event Date 07/11/2018

Event Type  Injury  

Manufacturer Narrative

Review of the device history records notes no material nonconformances, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions nor labeling that may have caused or contributed to this mode of failure.

Event Description

The patient experienced dislocation after bipolar hip arthroplasty.The physician performed a closed repair at which time the cup and head disconnected.A revision was performed and the bipolar head was replaced.

• Brand Name: PIVOT
• Type of Device: BIPOLAR FEMORAL HEAD
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer (Section G): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer Contact: drew weaver ; 12187 s. business park drive; draper, UT 84020 ; 8015539991
• MDR Report Key: 7805631
• MDR Text Key: 117896988
• Report Number: 1722511-2018-00028
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050966
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: 133-2249
• Device Lot Number: A113370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 92 YR