MAUDE Adverse Event Report: LIMACORPORATE S.P.A. H-MAX S; H-MAX S STANDARD UNCEMENTED STEMS

Model Number 4250.02.090

Device Problems Device Slipped (1584); Material Protrusion/Extrusion (2979)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

The check of dhr of the lot# (201109627) of stem involved did not show any anomaly.No other complaints have been reported on the lot# involved, on a total of (b)(4) h-max s femoral stems manufactured with this lot#.We will submit a final mdr once the investigation will be concluded.

Event Description

Hip revision surgery due to implant loosening after 71 months from primary surgery.According to the info reported, patient started feeling pain and so the stem, well fixed in the canal but slight wiggle at the top, was pulled out and a restoration stem was implanted.Even the original poly liner was replaced with a protruded poly liner.Event happened in (b)(6).

• Brand Name: H-MAX S
• Type of Device: H-MAX S STANDARD UNCEMENTED STEMS
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale,52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A.; via nazionale,52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer Contact: giulio puppa
• MDR Report Key: 6398526
• MDR Text Key: 69738494
• Report Number: 3008021110-2017-00012
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K112091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4250.02.090
• Device Lot Number: 201109627
• 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