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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIMACORPORATE S.P.A. STAND. ACETAB. CEM. CUP Ø52MM; CEMENTED CUPS (UHMWPE) DIA. 52 FOR HEAD DIA28MM
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LIMACORPORATE S.P.A. STAND. ACETAB. CEM. CUP Ø52MM; CEMENTED CUPS (UHMWPE) DIA. 52 FOR HEAD DIA28MM Back to Search Results
Model Number 5618.50.040
Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)
Patient Problems Joint Dislocation (2374); Implant Pain (4561)
Event Date 11/14/2022
Event Type  Injury  
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 took place on (b)(6) 2010.The patient is male, 76 years old, 96 kg.This event occurred in czech republic.
 
Manufacturer Narrative
No pre-existing anomaly detected by the check ok the device history records of the lot number involved (1002850).This is the first and only complaint registered 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 took place on (b)(6) 2010.The patient is male, 76 years old, 96 kg.This event occurred in czech republic.
 
Manufacturer Narrative
Checking the device history records and raw material certificate of the involved lot.1002850 - ster.1000146, no pre-existing anomaly was found on a total of (b)(4) items manufactured with the same lot number.According to our records, at least 27 out of 37 with lot.1002850 - ster.1000146 have been implanted and this is the only complaint received on this lot nr.Complaint source provided to limacorporate ten x-rays with the following date reference: (b)(6) 2010 - pre-operative primary surgery.(b)(6) 2010 - post-operative primary surgery.(b)(6) 2011 - 6 months post-operative primary surgery.(b)(6) 2013 - 2 years post-operative primary surgery.(b)(6) 2017 - 7 years post-operative primary surgery.(b)(6) 2019 - 9 years post-operative primary surgery.(b)(6) 2020 - 10 years post-operative primary surgery.(b)(6) 2021 - 11 years post-operative primary surgery.(b)(6) 2022 - 12 years post-operative primary surgery.(b)(6) 2023 - 7 months post-operative revision surgery.The x-rays received have been evaluated by a medical consultant.Following, the medical consultant comments: "the cemented cup was implanted in 2010.Seems to be correctly fixed.In 2017 loosening of the cup with moderate abrasion of the pe is already evident, revision would have been indicated.Until 2022 progressive loosening and consumption of bone stock can be identified.Revision in 2023 was done using an uncemented jumbo-cup.The fixation appears to be done correctly." the explanted devices were not returned for investigation; therefore no specific analysis can be performed on them.Based on the available information, we cannot determine with certainty the root cause for the event.The check of manufacturing charts and raw material certificate highlighted no pre-existing anomalies on components manufactured lot.Nr.Lot.1002850 - ster.1000146, therefore we can state they have been manufactured up to specifications and in line with relevant tests and checks.This event is classified as not product related.Pms data according to limacorporate pms data, the revision rate of cemented cups (family code: 5615/16/18/19/20/22/26.50.Xxx) due to dislocation and/or loosening is about (b)(4).No corrective actions required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.
 
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Brand Name
STAND. ACETAB. CEM. CUP Ø52MM
Type of Device
CEMENTED CUPS (UHMWPE) DIA. 52 FOR HEAD DIA28MM
Manufacturer (Section D)
LIMACORPORATE S.P.A.
via nazionale 52
villanova di san daniele, udine 33038
IT  33038
Manufacturer Contact
via naizonale 52
villanova di san daniele,, udine 33038, 33038
MDR Report Key17069155
MDR Text Key316800291
Report Number3008021110-2023-00068
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
K112158
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/27/2024
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 Number5618.50.040
Device Lot Number1002850
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/06/2023
Supplement Dates Manufacturer Received05/25/2023
Supplement Dates FDA Received03/04/2024
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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