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

Model Number	PHA04416
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, infection with the serratia marcescens bacteria.Hospital suspects that the ice and/or the bags containing it, used to prevent post-operative swallowing, may have been contaminated.The hospital also tested a third patient who had used mpo products.That third patient's exam was negative, so they discarded mpo products from being the cause of the infection.Previously hospitalized at hospital (b)(6) ((b)(6) 2025) and hospital (b)(6) ((b)(6) 2025).
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Additional Manufacturer Narrative
The alleged complaint is confirmed.Mpo was notified of two instances of infection involving mpo hip implants during (b)(6) 2026, at a single facility.Through additional correspondence with the reporting persons, additional information was obtained to confirm the presence of serratia marcescens for both instances.The reporting persons stated that the hospital does not consider the infection the result of the mpo devices as this specific bacterium is commonly associated with hospital acquired infections (hais) as supported by literature.Additionally, one additional patient also implanted with mpo products in the same hospital around the same time-tested negative for infection to support that it was likely unrelated to the mpo devices.Review of the device history record (dhr) for the subject lots indicates that these products met all established acceptance criteria throughout manufacturing processes, including all aspects associated with cleaning, sterile packaging, and sterilization processes.Furthermore, a review of historical complaint data confirms that mpo has not received any other complaint reports involving the subject manufacturing lots.There were also no complaint trends identified for other manufacturing lots of the same sterile batches.Infection is a known risk of any surgical procedure.Based on the supporting information provided by the hospital and no similar complaint reports for these manufacturing lots, the source of infection is most likely not associated with the mpo implants.Mpo will continue to monitor and trend for this complaint issue.

• Brand Name: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M
• 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: 24664845
• Report Number: 3010536692-2026-00057
• Device Sequence Number: 9290114
• Product Code: LZO
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K130376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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: PHA04416
• Device Catalogue Number: PHA04416
• Device Lot Number: 2042537
• Was Device Available for Evaluation?: No
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male