MAUDE Adverse Event Report: LIMACORPORATE S.P.A. STAND. ACETAB. CEM. CUP Ø48MM; CEMENTED CUPS (UHMWPE) DIA. 48 FOR HEAD DIA28MM,

Model Number 5618.50.020

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Implant Pain (4561)

Event Date 05/09/2022

Event Type  Injury  

Manufacturer Narrative

By the check of the device history records, no pre-existing anomaly was detected on the cemented cups that were released with lot number 1211582.This is the first and complaint received on this lot number.We will submit a final report after the investigation.

Event Description

Hip revision surgery due to dislocation, instability and pain.Excessive polyethylene abrasion was reported.The revision surgery was performed on (b)(6) 2022, the previous surgery on (b)(6) 2014.The patient is female, 75 years old, 80 kg.This event occurred in czech republic.

Manufacturer Narrative

By the check of the device history records, no pre-existing anomaly was detected on the cemented cups that were released with lot number 1211582.The raw material certificate was also checked without detecting any deviation.According to our records, at least 52 cups belonging to lot 1211582 have already been implanted and this is the first and only complaint received on this lot number.The following x-rays were provided by the complaint source: x-rays dated (b)(6) 2014.X-rays dated (b)(6) 2014.X-rays dated (b)(6) 2014.X-rays dated (b)(6) 2015.X-rays dated (b)(6) 2018.X-rays dated (b)(6) 2019.X-rays dated (b)(6) 2022.X-rays dated (b)(6) 2022.X-rays evaluation was requested to our medical consultant.He commented that the cup implanted in 2014 was not a highly crosslinked polyethylene and that "starting in 2018 abrasion can be noted, progressing rapidly.The aggressive pe debris lead to definite loosening in 2020.Loosening of the cup is clearly evident, the stem most likely as well.Revision was well indicated and performed sufficiently." the explanted devices were not returned for investigation, therefore no specific analysis could be performed on them.Based on the available information, we cannot determine with certainty the root cause of the reported issue.The x-rays analysis confirmed the loosening of the cup and polyethylene wear over the years.Without the possibility to analyze the device, no further analysis can be performed, other than the check of the device history records and raw material certificate, which confirmed the absence of pre-existing anomalies on the involved lot number.In conclusion, we can state that the involved device has been manufactured up to specifications and in line with relevant tests and checks.This event is therefore 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 0,01% 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 due to dislocation, instability and pain.Excessive polyethylene abrasion was reported.The revision surgery was performed on (b)(6) 2022, the previous surgery on (b)(6) 2014.The patient is female, 75 years old, 80 kg.

• Brand Name: STAND. ACETAB. CEM. CUP Ø48MM
• Type of Device: CEMENTED CUPS (UHMWPE) DIA. 48 FOR HEAD DIA28MM,
• 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: 17069156
• MDR Text Key: 316588480
• Report Number: 3008021110-2023-00069
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 5618.50.020
• Device Lot Number: 1211582
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/23/2024
• 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