MAUDE Adverse Event Report: LIMACORPORATE S.P.A. DELTA-TT ACETAB.CUP Ø52 MM; ACETABULAR CUPS (TI6AL4V) DIA. 52MM FOR LINER SIZE

Model Number 5552.15.520

Device Problem Patient Device Interaction Problem (4001)

Event Date 07/27/2022

Event Type  Injury  

Event Description

Surgery performed on (b)(6) 2022, due to infection.Surgical cleaning was performed.The implant was left in situ.The following is the list of the components involved: h-max s standard fem.Stem #14 (product code 4250.20.140, lot number 2202209, sterilization number 2200097).Fem.Modular head - s ø36mm (product code 5010.42.361, lot number 7011676347).Delta-tt acetab.Cup ø52 mm (product code 5552.15.520, lot number 2209021, sterilization number 2200145).Delta liner øint 36mm # medium (product code 5885.42.258, lot number 7011690754, product not sold in us).The previous surgery was performed on (b)(6) 2022.The patient is 41 years old.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 41 h-max s standard fem.Stem #14 that belong to product code 4250.20.140, lot number 2202209, sterilization number 2200097.No pre-existing anomaly on the 234 fem.Modular head - s ø36mm that belong to product code 5010.42.361, lot number 7011676347.No pre-existing anomaly on the 55 delta-tt acetab.Cup ø52 mm that belong to product code 5552.15.520, lot number 2209021, sterilization number 2200145.No pre-existing anomaly on the 68 delta liner øint 36mm # medium that belong to product code 5885.42.258, lot number 7011690754.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.

Manufacturer Narrative

The sterilization charts of the involved devices were checked with the following results: - no pre-existing anomaly on the 41 h-max s standard fem.Stem #14 that belong to product code 4250.20.140, lot number 2202209, sterilization number 2200097.- no pre-existing anomaly on the 234 fem.Modular head - s ø36mm that belong to product code 5010.42.361, lot number 7011676347.- no pre-existing anomaly on the 55 delta-tt acetab.Cup ø52 mm that belong to product code 5552.15.520, lot number 2209021, sterilization number 2200145.- no pre-existing anomaly on the 68 delta liner øint 36mm # medium that belong to product code 5885.42.258, lot number 7011690754.To perform a deeper analysis, the following information were requested to the complaint source: - x-rays.- information on the germ responsible for the infection.- additional information about the suspect of pre-existing infection signaled by the complaint source, - patient's clinical information relevant for the analysis.The complaint source could only share the radiograph taken on (b)(6), thus before the surgery dated (b)(6) 2022.The only available radiograph was shared with our medical consultant, who commented: "the x-ray, (b)(6) 2022, shows a preformed spacer that is only used for temporary stabilization after infection.I understand that there has been re-implantation (b)(6).Obviously into a still infected site, that required re-revision some 2 weeks later.Unfortunately, it must be feared that infection may still be going on as the last implants were not exchanged." in conclusion: - the sterilization charts of the involved devices confirmed that they were regularly sterilized before being placed on the market, - based on the available information and investigation performed, infection was probably already present before implantation of lima devices.On the basis of the analyses performed, the cause of the infection cannot be determined with certainty, however it seems to be linked to other factors not related to the devices themselves.Event classified as not product related.Pms data: according to our pms data, we can estimate a revision rate of delta tt cups (family codes 5552.15.Xxx) due to infection of about 0.02%.No corrective action needed following this complaint, limacorporate will continue monitoring the market to promptly detect any further similar event.

Event Description

Surgery performed on (b)(6) 2022, due to infection.Surgical cleaning was performed.The implant was left in situ.The following is the list of the components involved: - h-max s standard fem.Stem #14 (product code 4250.20.140, lot number 2202209, sterilization number 2200097).- fem.Modular head - s ø36mm (product code 5010.42.361, lot number 7011676347).- delta-tt acetab.Cup ø52 mm (product code 5552.15.520, lot number 2209021, sterilization number 2200145).- delta liner øint 36mm # medium (product code 5885.42.258, lot number 7011690754).The previous surgery was performed on (b)(6) 2022.The complaint source stated that they could not exclude that the infection was already present.The patient is 41 years old.Event occurred in italy.

• Brand Name: DELTA-TT ACETAB.CUP Ø52 MM
• Type of Device: ACETABULAR CUPS (TI6AL4V) DIA. 52MM FOR LINER SIZE
• 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: 15435512
• MDR Text Key: 300042080
• Report Number: 3008021110-2022-00082
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K112898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/16/2022

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: 5552.15.520
• Device Lot Number: 2209021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 09/16/2022
• Supplement Dates Manufacturer Received: 09/06/2022
• Supplement Dates FDA Received: 02/12/2024
• 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