MAUDE Adverse Event Report: LIMACORPORATE S.P.A. H-MAX S LATERAL. FEM. STEM #8; H-MAX S LATERALIZING UNCEMENTED STEMS (TI6AL4V + HA) N.8 (MEH-JDI-KWY)

Model Number 4251.20.080

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

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

By checking the manufacturing chart of the involved lot#, no pre-existing anomaly was found on the (b)(4) pieces placed on the market with lot# 1507213.No other complaint received on lot# 1507213.We will proceed with further investigations and submit a final mdr once concluded.

Event Description

Hip revision surgery, due to aseptic loosening of the stem, performed on (b)(6) 2018.Previous surgery took place on (b)(6) 2015.It was reported to us that the stem had no bone ongrowth at all and it came out very easily.During previous surgery (2015) the femur had been fractured while implanting the definitive stem and according to the info provided, the fracture never really healed.

• Brand Name: H-MAX S LATERAL. FEM. STEM #8
• Type of Device: H-MAX S LATERALIZING UNCEMENTED STEMS (TI6AL4V + HA) N.8 (MEH-JDI-KWY)
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 7836647
• MDR Text Key: 118877344
• Report Number: 3008021110-2018-00072
• 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
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 4251.20.080
• Device Lot Number: 1507213
• 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