MAUDE Adverse Event Report: LIMACORPORATE S.P.A. H-MAX S STANDARD UNCEMENTED STEMS (TI6AL4V + HA) N.12; H-MAX S STANDARD UNCEMENTED STEMS (TI6AL4V + HA) N.12 (MEH-JDI-KWY)

Model Number 4250.20.120

Device Problems Loose or Intermittent Connection (1371); Fitting Problem (2183)

Patient Problem Failure of Implant (1924)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

By checking the dhrs of the lot# involved (1616787) no pre-existing anomaly was found on the (b)(4) stems placed on the market with the same lot#.First and only complaint received on this lot#.We will submit a final mdr as soon as the investigation will be concluded.

Event Description

Revision surgery due to stem subsidence performed on (b)(6) 2019.Previous surgery took place on (b)(6) 2019.According to the info received, the stem implanted on (b)(6) 2019 may have been undersized.Event happened in (b)(6).

• Brand Name: H-MAX S STANDARD UNCEMENTED STEMS (TI6AL4V + HA) N.12
• Type of Device: H-MAX S STANDARD UNCEMENTED STEMS (TI6AL4V + HA) N.12 (MEH-JDI-KWY)
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 9353745
• MDR Text Key: 167344343
• Report Number: 3008021110-2019-00131
• 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: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 4250.20.120
• Device Lot Number: 1616787
• 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