MAUDE Adverse Event Report: LIMACORPORATE S.P.A. H-MAX S LATERALIZED FEMORAL STEM #14; H-MAX S LATERALIZING UNCEMENTED STEMS (TI6AL4V + HA) N.14

Model Number 4251.20.140

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 12/06/2021

Event Type  Injury  

Manufacturer Narrative

Checking the dhr of the involved lot #1003576, no pre-existing anomaly was found on the components that were released on the market with the same lot #.This is the first and only complaint received on this lot #.We will submit a final mdr as soon as the investigation will be completed.

Event Description

Revision surgery of the left hip prosthesis performed on (b)(6) 2021, due to loosening of the h-max s lateralized femoral stem #14 (product code 4251.20.140, lot #1003576 - ster.1000113).It was reported that the cause of the loosening is not known.The following components were removed and replaced: h-max s lateralized femoral stem #14 (product code 4251.20.140, lot #1003576 - ster.1000113).Femoral modular head - s ø32mm (product code 5010.42.321, lot #1481349 - ster.1400219).Delta protruded liner øint 32mm #l (product code 5886.51.160, lot #1106174 - ster.1100228).Previous surgery took place on (b)(6) 2014.Patient is a male, (b)(6).It was reported he has a high bmi.Event happened in (b)(6).

Manufacturer Narrative

By checking the manufacturing charts of the involved lot #1003576, no pre-existing anomaly was found on a total of (b)(4) manufactured with the same lot#.According to our records, at least (b)(4) femoral stems with lot #1003576 - ster.1000113 have been implanted and this is the only complaint received on this lot #.Explants analysis: items involved were not available to be returned to limacorporate for further analysis.X-rays analysis: limacorporate received one x-ray referring to pre-operative revision surgery.The x-ray received - dated (b)(6) 2021 - has been evaluated by a medical consultant.Following, the medical consultant comments: "from the xray the stem indeed appears to be loosened as might be concluded from the cortical thickening at the lateral side of the femur and a small lucent line proximally.Beside that there is no obvious reason for the failure visible.The size as well as the position of the stem appears correct.Maybe the implant was not optimally chosen for the patient.A metaphyseal anchorage together with lateralization might be too much for a patient with such high bmi.Maybe a c2 would have been more appropriate but that is purely speculative.Another possibility might be found in some low virulent infection, again not easy to verify unless the system was sent to sonication.In summary: loosening just happens sometimes, without obvious reason" considering that: · check of the manufacturing charts highlighted no anomalies on the total number of components manufactured with lot# 1003576; · according to the medical consultant "maybe the implant was not optimally chosen for the patient [.] another possibility might be found in some low virulent infection [.].In summary: loosening just happens sometimes, without obvious reason" ; we can state that the event was not product related.Pms data: according to limacorporate pms data, revision rate of h-max s femoral stems - belonging to the family codes 4250.20.Xxx and 4251.20.Xxx - due to loosening is (b)(4).Based on the root cause analysis performed and according to the relevant pms data, no corrective actions required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.Note: this is a final mdr.

Event Description

Revision surgery of the left hip prosthesis performed on (b)(6), 2021, due to loosening of the h-max s lateralized femoral stem #14 (product code 4251.20.140, lot #1003576 - ster.1000113).It was reported that the cause of the loosening is not known.The following components were removed and replaced: · h-max s lateralized femoral stem #14 (product code 4251.20.140, lot #1003576 - ster.1000113).· femoral modular head - s ø32mm (product code 5010.42.321, lot #1481349 - ster.1400219).· delta protruded liner øint 32mm #l (product code 5886.51.160, lot #1106174 - ster.1100228).Previous surgery took place on (b)(6), 2014.Patient is a male, 67 years old.It was reported he has a high bmi.Event happened in australia.

• Brand Name: H-MAX S LATERALIZED FEMORAL STEM #14
• Type of Device: H-MAX S LATERALIZING UNCEMENTED STEMS (TI6AL4V + HA) N.14
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 13024577
• MDR Text Key: 286496356
• Report Number: 3008021110-2021-00105
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K160011
• 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: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 4251.20.140
• Device Lot Number: 1003576
• 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