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

Model Number	PHA04418
Medical Device Problem Codes	Mechanical Jam (2983); Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, an info received from local sales rep that a curious frequency of revisions (two done early 2023, and other two scheduled for next (b)(6) 2023 in two hospitals) of dynasty a-class liners due to high wear rate after 6 to 8 yrs post op.No enough info available regarding the already-done revisions, we will collect info and explants from the scheduled ones.Additional information received on 07/18/2023: allegedly, from my early investigation of the third liner explant, it seemed much more a locking mechanism issue than wear, as the liner does not look thinned out, and the femoral head showed a black mark demonstrating friction against the cup, which might mean that the liner flipped into the cup.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• 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
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 17584312
• Report Number: 3010536692-2023-00154
• Device Sequence Number: 4880064
• 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: 2013
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2024

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: 1529561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male