MAUDE Adverse Event Report: LIMACORPORATE S.P.A. H-MAX S LATERALIZED FEMORAL STEM #8; H-MAX S LATERALIZING UNCEMENTED STEMS (TI6AL4V + HA) N.8

Model Number 4251.20.080

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/18/2022

Event Type  Injury  

Manufacturer Narrative

Checking the dhr of the involved lot #1508522, 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

Hip revision surgery performed on (b)(6) 2022, due to implant loosening.According to the complaint source, the reason of loosening is not known.The following components were removed and replaced: h-max s lateralized femoral stem #8 (product code 4251.20.080, lot #1508522 - ster.1500225) femoral modular head - s ø32mm (product code 5010.09.321, lot #1516902 - ster.1500382) delta neutral liner øint 32mm #m (product code 5885.51.158, lot #1600230 - ster.1600055) previous surgery took place on (b)(6) 2016.Patient is a female, (b)(6) years old.It is reported she has a high bmi.Event happened in (b)(6).

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #1508522, 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) stems with lot #1508522 - ster.1500225 have been implanted and this is the only complaint received on this lot #.Explants analysis: the items involved were not available to be returned to limacorporate for further analysis.X-rays analysis: limacorporate received a total of one x-ray referring to pre-operative revision surgery.The x-ray received - dated (b)(6) 2021 - and a picture of the explanted components have been evaluated by a medical consultant.Following, the medical consultant comments: "there is obvious stem loosening visible on the x-ray.Reason for loosening cannot be evaluated without seeing previous x-rays.There might have been some failure during implantation (probably too small stem) or low-grade infection.If none of the possible reasons apply we can only say: aseptic loosening just happens in a certain percentage of cases (especially in patients with high bmi), without finding any special reason".Based on the performed investigation we cannot define the root cause of the event.According to the medical consultant, the reason for stem loosening might have been a surgical error or an infection, however no definitive evaluation can be done as no additional x-rays are available.In consideration of the above and of the review of the manufacturing charts (which found no anomalies on the total number of components manufactured with lot #1508522), 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

Hip revision surgery performed on (b)(6), 2022, due to implant loosening.According to the complaint source, the reason of loosening is not known.It was reported that pain onset started in (b)(6) 2021.The following components were removed and replaced: · h-max s lateralized femoral stem #8 (product code 4251.20.080, lot #1508522 - ster.1500225).· femoral modular head - s ø32mm (product code 5010.09.321, lot #1516902 - ster.1500382).· delta neutral liner øint 32mm #m (product code 5885.51.158, lot #1600230 - ster.1600055).Previous surgery took place on (b)(6), 2016.Patient is a female, 84 years old.It is reported she has a high bmi.Event happened in australia.

• Brand Name: H-MAX S LATERALIZED FEMORAL STEM #8
• Type of Device: H-MAX S LATERALIZING UNCEMENTED STEMS (TI6AL4V + HA) N.8
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 13343102
• MDR Text Key: 289190765
• Report Number: 3008021110-2022-00002
• 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: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 4251.20.080
• Device Lot Number: 1508522
• 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): Other