MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 S; HIP COMPONENT

Model Number PHA04414

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Allegedly, patient was revised due to prosthesis dislocation.Cotyle and liner are not mpo products.Components not revised: profemur® l hip stem size 8 ha coated, pha05516, lot w10359386.

• Brand Name: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 S
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 10061103
• MDR Text Key: 191111015
• Report Number: 3010536692-2020-00358
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: M684PHA044141
• UDI-Public: M684PHA044141
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K130376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PHA04414
• Device Catalogue Number: PHA04414
• Device Lot Number: X04416532
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/02/2019
• Date Manufacturer Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR