MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 L; HIP COMPONENT

Model Number	PHA04412
Health Effect - Clinical Code	Unequal Limb Length (4534)
Date of Event	01/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, the neck and head were replaced for leg length correction.Additionally, re-substitution of cup due to loosening of another company's cup.Mpo's tl size 1 stem side was fine.(b)(4).
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Additional Manufacturer Narrative
Additional information received on 03/11/2022 no longer reportable, as indicated by mah on march 11th, because the information was clarified by the mah with pmda.The cup had loosening but the manufacturer is another company.There is no alleged deficiency against the neck and head, please void the following report.

• Brand Name: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 L
• 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: 13472273
• Report Number: 3010536692-2022-00041
• Device Sequence Number: 4690884
• Product Code: LZO
• UDI-Device Identifier: M684PHA044121
• UDI-Public: M684PHA044121
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 03/17/2022

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: PHA04412
• Device Catalogue Number: PHA04412
• Device Lot Number: 1862247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/20/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 03/18/2022
• 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 Sex: Unknown