MAUDE Adverse Event Report: LIMACORPORATE S.P.A. FEM. MODULAR HEAD - M Ø28MM 2; MODULAR FEMORAL HEADS (COCRMO) DIA. 28MM M TAPER 12/14

Model Number 5010.09.282

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Event Date 09/19/2022

Event Type  Injury  

Event Description

Revision surgery performed on (b)(6) 2022, due to infection.The following is the list of the components involved: fem.Modular head - m ø28mm (product code 5010.09.282, lot number 2208982, sterilization number 2200141).Lock bipol.Self-cent.Head ø48 (product code 5527.05.480, lot number 2203180, sterilization number 2200065, product not sold in us).The previous surgery took place on (b)(6) 2022.The event occurred in italy.

Manufacturer Narrative

The sterilization charts of the involved devices were checked with the following results: no pre-existing anomaly on the 48 fem.Modular head - m ø28mm that belong to product code 5010.09.282, lot number 2208982, sterilization number 2200141.No pre-existing anomaly on the 24 lock bipol.Self-cent.Head ø48 that belong to product code 5527.05.480, lot number 2203180, sterilization number 2200065.Therefore, we can state that the involved components were regularly sterilized before being placed on the market.We will submit a final report after the conclusion of the investigation.

Event Description

Revision surgery performed on (b)(6) 2022, due to infection.The following is the list of the components involved: fem.Modular head - m ø28mm (product code 5010.09.282, lot number 2208982, sterilization number (b)(4)) lock bipol.Self-cent.Head ø48 (product code 5527.05.480, lot number 2203180, sterilization number (b)(4)).The previous surgery took place on (b)(6) 2022.The patient is 81 years old.Past medical history: neurosis, gastro/esophageal reflux disease.Appendectomy, cesarean section, ovarian cyst operation.This event occurred in italy.

Manufacturer Narrative

The sterilization charts of the involved devices were checked with the following results: - no pre-existing anomaly on the 48 fem.Modular head - m ø28mm that belong to product code 5010.09.282, lot number 2208982, sterilization number (b)(4) - no pre-existing anomaly on the 24 lock bipol.Self-cent.Head ø48 that belong to product code 5527.05.480, lot number 2203180, sterilization number (b)(4) therefore, we can state that the involved components were regularly sterilized before being placed on the market.No other complaints due to infection is registered in our system concerning ster.Numbers (b)(4).Very few information is available on this case, specifically, the following details were requested to the complaint source but never shared with limacorporate: - x-rays - germ responsible for the infection reported without the possibility to analyze additional information, no deep analysis can be performed, therefore we cannot determine the cause of the infection.Nevertheless, the check of the sterilization charts confirmed that the devices involved were regularly sterilized, no anomaly detected.In conclusion, it seems that the infection was caused by external factors not related to the products.Pms data based on limacorporate's pms data, we estimate a revision rate of the femoral heads belonging to family codes 5010.09.Xxx due to infection of about (b)(4).No corrective action needed following this complaint.Limacorporate will continue to monitor the market to promptly detect any further similar event.

• Brand Name: FEM. MODULAR HEAD - M Ø28MM 2
• Type of Device: MODULAR FEMORAL HEADS (COCRMO) DIA. 28MM M TAPER 12/14
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via naizonale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 15649331
• MDR Text Key: 302169051
• Report Number: 3008021110-2022-00095
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K112158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2022

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
• Device Model Number: 5010.09.282
• Device Lot Number: 2208982
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: 09/26/2022
• Supplement Dates FDA Received: 11/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention