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)

Event Date 01/20/2023

Event Type  Injury  

Event Description

Hip revision surgery performed on (b)(6) 2023, due to loosening of the h-max s lateralized femoral stem #8 (product code 4251.20.080, lot #0903447 - ster.0900188).According to the received information, the stem was undersized and had subsided.The following components got explanted: · h-max s lateralized femoral stem #8 (product code 4251.20.080, lot #0903447 - ster.0900188); femoral modular head - xl ø28mm (product code 5010.09.284, lot #1106706 - ster.1100185); delta neutral liner øint 28mm #s (product code 5885.51.055, lot #0901232 - ster.0900164); the stem was upsized by two sizes.The femoral head and liner were upsized from 28mm to 32mm.Previous surgery took place on (b)(6) 2011.Patient is a female.Event happened in new zealand.

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #0903447, no pre-existing anomaly was found on a total of 10 items manufactured with the same lot #.Device analysis the items involved were not available to be returned to limacorporate for further analysis.No additional details were available on this post-operative issue, specifically pre-operative x-rays related to the revision surgery were requested to the complaint source but they were not available.Based on the very few information received, we are not able to further investigate the root cause of the event.However, considering that: check of the manufacturing charts highlighted no anomalies on the components manufactured with lot #0903447; according to the received information, the stem was undersized; 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 0.01%.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 combined initial-final report.

• 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
• Manufacturer (Section G): LIMACORPORATE S.P.A.; IT
• MDR Report Key: 16598313
• MDR Text Key: 311853499
• Report Number: 3008021110-2023-00030
• 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
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 4251.20.080
• Device Lot Number: 0903447
• 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