MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PRIME BF MULTI-HOLE; HIP COMPONENT

Model Number	P3SBMB48
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, on (b)(6) 2022, patient's ct revealed that the p2lelb32 prime e-class liner 15° lip 32mm group b was found to be possibly dislocated.At this time, only 3 items would be return.#9312; prime e-class liner 15°lip 32mm group b: p2lelb32 #9313; femoral head biolox® delta ceramic 12/14 - 32l: pha04412.#9314; modular neck ar/vv 1 long: pha01224.Japan.(b)(4).
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: PRIME BF MULTI-HOLE
• Common Device Name: 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: 15155909
• Report Number: 3010536692-2022-00263
• Device Sequence Number: 20163779
• Product Code: LPH
• UDI-Device Identifier: M684P3SBMB481
• UDI-Public: M684P3SBMB481
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2022

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: P3SBMB48
• Device Catalogue Number: P3SBMB48
• Device Lot Number: 1877625
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/14/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 09/13/2022
• 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: 82 YR
• Patient Sex: Female