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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
Event or Problem Description
Allegedly, patient was revised due to pain without loosening.Product not revised: acetabular cup "procotyl® l" beaded coated s.54 group e, catalog # pha0-6214, lot # 10746483501, qty 1.Rim-lock biolox delta ceramic liner 36 group e, catalog # pha04510, lot # x10473186, qty 1.
Additional Manufacturer Narrative
See investigation attached.- attachment: [fdatimingletter.Pdf, ripojuly2019signed.Pdf].

• 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: 8850329
• Report Number: 3010536692-2019-00953
• Device Sequence Number: 10845022
• Product Code: LZO
• UDI-Device Identifier: M684PHA044181
• UDI-Public: M684PHA044181
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K130376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

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: 07/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 02/05/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR