MAUDE Adverse Event Report: LIMACORPORATE S.P.A. FEM. MODULAR HEAD - L Ø28MM; BIOLOX DELTA HEAD 28MM #L

Model Number 5010.42.283

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/30/2022

Event Type  malfunction  

Manufacturer Narrative

By the check of the device history records of the lot number involved, no anomaly was detected.Investigation is currently ongoing, a final report will be submitted as soon as completed.

Event Description

Inside the package of the ceramic femoral head l ø28mm with code 5010.42.283 lot 1581651 ster.2200243, a metal femoral head was found (5010.09.284 lot.1203396).The surgery was positively completed with few minutes of delay, a 28mm medium ceramic head was implanted.The incident occurred in italy.

Manufacturer Narrative

Investigation during the preliminary investigation, the manufacturing charts of the ceramic femoral head with code 5010.42.283, lot number 1581651, sterilization number 2200243 and of the metal femoral head with code 5010.09.284, lot number 1203396, sterilization number 2200243 were checked and no pre-existing anomaly was found.Both the femoral heads were re-worked and associated to the same sterilization lot 2200243.Each work order is composed by one single item.The two heads were washed together, and the subsequent phases were performed with a difference of 5-6 minutes with one each other.For this reason, we can reckon that the mismatch is related to a human mistake.Therefore, a corrective action preventive action (capa), with internal code (b)(4), was opened to reduce the risk of recurrence of similar non-conformities.Moreover , lima corporate performed the recall of the ceramic femoral head inside the packaging of a metal femoral head that was still on the field, through a field safety corrective action (fsca) closed on march 17th,2023.The fsca above-mentioned does not include a device with a combination of product code and lot number manufactured or distributed in united states; for this reason, no further report was submitted to the fda for the field action.Pms data according to the relevant pms data, the occurrence rate of this type of issues related to the femoral heads belonging to the family code 5010.42.Xxx is about (b)(4)%.For this complaint, a specific field safety corrective action (fsca) was performed, as described in the above section (no fda relevant).Lima corporate will continue monitoring the market to promptly detect any further similar issue.This is a final mdr.

Event Description

During a hip surgery performed on (b)(6) 2022, inside the package of the ceramic femoral head l ø28mm with code 5010.42.283 lot 1581651 ster.2200243, a metal femoral head was found (5010.09.284 lot.1203396).The surgery was positively completed with few minutes of delay, a 28mm medium ceramic head was implanted.The incident occurred in italy.

• Brand Name: FEM. MODULAR HEAD - L Ø28MM
• Type of Device: BIOLOX DELTA HEAD 28MM #L
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 16145792
• MDR Text Key: 308402238
• Report Number: 3008021110-2023-00001
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K141327
• 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: 04/20/2023

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: 5010.42.283
• Device Catalogue Number: 5010.42.283
• Device Lot Number: 1581651
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/20/2023
• 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): Other