MAUDE Adverse Event Report: LIMACORPORATE S.P.A. STAND. ACETAB. CEM. CUP Ø46MM; CEMENTED CUPS (UHMWPE) DIA. 46 FOR HEAD DIA28MM

Model Number 5618.50.015

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

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

Event Date 02/21/2022

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) 2011.The patient is female, 81 years old, 75 kg.This event occurred in czech republic.

Manufacturer Narrative

No pre-existing anomaly was detected by the check of the device history records of the lot number involved (1006859).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.Stand.Acetab.Cem.Cup ø46mm (product code: 5618.50.015, lot.Nr.1006859 - ster.1100108) the revision surgery was performed on (b)(6) 2022, the previous surgery took place on (b)(6) 2011.The patient is female, 81 years old, 75 kg.Event occurred in czech republic.

Manufacturer Narrative

Checking the device history records of the involved lot.Nr.1006859 - ster.1100108, no pre-existing anomaly was found on a total of 52 items manufactured with the same lot number.According to our records, at least 34 out of 52 with lot.Nr.1006859 - ster.1100108 have been implanted and this is the only complaint received on this lot nr.Even though requested the following details were not provided to limacorporate: pictures of the explanted device/s.Information on other components explanted, if any.The complaint source provided to limacorporate seven x-rays with the following date reference: 13.11.2011 - pre-operative primary surgery.03.01.2012 - post-operative primary surgery.13.11.2013 - 2 years post-operative primary surgery.08.10.2020 - 9 years post-operative primary surgery.28.01.2022 - 1-week post-operative revision surgery the x-rays received have been evaluated by a medical consultant.Following, the medical consultant comments: "the primary surgery done in 2011 used cemented implants.I presume the cup used was an older type, not using highly crosslinked pe.In combination with a metal head, it is not unusual that rapid abrasion may occur in such pairing.The histological evaluation confirmed massive foreign body reaction of the surrounding tissue caused by the debris, loosening is to be expected in such situation, even also involving the stem.There was no sign of infection.The revision has been done properly using uncemented implants.I do not see any reason for a complaint." 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 with lot.Nr.1006859 - ster.1100108, 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 0,01%.No corrective actions required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.This is a final mdr report.

• Brand Name: STAND. ACETAB. CEM. CUP Ø46MM
• Type of Device: CEMENTED CUPS (UHMWPE) DIA. 46 FOR HEAD DIA28MM
• 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 33038
• MDR Report Key: 17069154
• MDR Text Key: 316588345
• Report Number: 3008021110-2023-00070
• 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
• Report Date: 02/23/2024

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 Number: 5618.50.015
• Device Lot Number: 1006859
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: 05/25/2023
• 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