MAUDE Adverse Event Report: LIMACORPORATE S.P.A. STAND. ACETAB. CEM. CUP Ø54MM

Model Number 5618.50.050

Device Problems Material Integrity Problem (2978); Patient Device Interaction Problem (4001)

Patient Problem Implant Pain (4561)

Event Date 12/05/2022

Event Type  Injury  

Event Description

Hip revision surgery performed on (b)(6) 2022.The reported cause of the revision was early loosening of both the stem (product code 3515.05.040, lot 1407845) and acetabular cup (product code 5618.50.050, lot 1413046).Excessive wear of the polyethylene was reported.The previous surgery took place on (b)(6) 2015.This event occurred in czech republic.The product code 3515.05.040 is not marketed in the usa.

Manufacturer Narrative

By the check of the device history records, no pre-existing anomaly was detected on the cups released with lot number 1413046 and on the stems released with lot number 1407845.This is the first and only complaint registered on these lot numbers.A final report will be submitted after the investigation.

Manufacturer Narrative

By the check of the device history records, no pre-existing anomaly was detected on the cups released with lot number 1413046 and on the stems released with lot number 1407845.This is the first and only complaint registered on these lot numbers.The following x-rays were provided by the complaint source: - x-rays taken before initial surgery, dated (b)(6) 2014 - x-rays taken after the initial surgery, dated (b)(6) 2015, (b)(6) 2016, (b)(6) 2017, (b)(6) 2019, (b)(6) 2022 - x-rays taken after the revision surgery, dated (b)(6) 2023.The x-rays and available information were analyzed by a medical consultant, he commented: "loosening of the cemented components is evident.I do not see any sign of polyethylene wear but debris and osteolysis may be present due to high rate of cement particles ("cement-disease").Are you sure there has not been additional surgery in 2016? the amount of x-rays raises some doubt and on one i see a an element that might be identified as a palacos bead, indicating some revision (dair) because of infection? the last revision has been done appropriately, given no additional infection has been present." the complaint source reported that a surgery was performed on (b)(6) 2016, but it was not a revision surgery ("stem puncture").The involved devices were not returned, therefore no specific analysis could be performed on them.On the basis of the available information, we cannot determine the cause of the loosening reported.The check of the device history records confirmed the involved lot numbers were manufactured up to specifications and in line with the relevant checks and tests.This event is classified as not product related.Pms data according to limacorporate pms data, the revision rate of cemented cups (family codes 5615/16/18/19/20/22/26.50.Xxx) due to dislocation and/or loosening is about (b)(4).No other revision surgery due to loosening of cemented sl stems belonging to family codes 3515.05.Xxx is registered in our systems (specific revision rate lower than (b)(4)).No corrective actions required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar event.

Event Description

Hip revision surgery performed on (b)(6) 2022.The reported cause of the revision was early loosening of both the stem (product code 3515.05.040, lot 1407845) and acetabular cup (product code 5618.50.050, lot 1413046).Excessive wear of the polyethylene was reported.The previous surgery took place on (b)(6) 2015.The patient is male, born in 1945, 195cm, 105kg.This event occurred in czeck republic.The prodcut code 3515.05.040 is not marketed in the usa.

• Brand Name: STAND. ACETAB. CEM. CUP Ø54MM
• Type of Device: STAND. ACETAB. CEM. CUP Ø54MM
• 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: 16984936
• MDR Text Key: 315845836
• Report Number: 3008021110-2023-00055
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 5618.50.050
• Device Lot Number: 1413046
• Is the Reporter a Health Professional?: No
• 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