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

Model Number	PHA04418
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, patient was revised due to dislocation , subluxation and malalignment stem.Revision njr number: 4502611.Side:r.Primary asa: p2 - mild disease not incapacitating.No information provided for stem.Additional information received on 10/08/2020 from (b)(6): adding a new incident for the stem with partial product information.
Event or Problem Description
Allegedly, patient was revised due to dislocation , subluxation and malalignment stem.Revision njr number: 4502611.Side:r.Primary asa: p2 - mild disease not incapacitating.No information provided for stem.Additional information received on 10/08/2020 from (b)(6): adding a new incident for the stem with partial product information additional information received on 11/09/2020 from (b)(6) : adding stem product number and lot batch.Mhra reference no: (b)(4).

• Brand Name: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 L
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10765453
• Report Number: 3010536692-2020-00672
• Device Sequence Number: 14419180
• Product Code: LZO
• UDI-Device Identifier: M684PHA044181
• UDI-Public: M684PHA044181
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K130376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2021

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: Other
• Device Model Number: PHA04418
• Device Catalogue Number: PHA04418
• Device Lot Number: X09445476
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 01/08/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention