MAUDE Adverse Event Report: LIMACORPORATE S.P.A. H-MAX S LATERALIZED UNCEMENTED STEM

Model Number 4251.20.110

Device Problems Inadequacy of Device Shape and/or Size (1583); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 11/15/2016

Event Type  Injury  

Manufacturer Narrative

The check of the dhr of the lot # involved (stem: lot #201516301; head: lot# 201580046; acetabular cup: lot # 201508570; liner: lot # 201581452) did not show any anomalies on the overall number of pieces manufactured with these lot#.This is the first similar complaint reported on these lot #.We will submit a final mdr once our investigation is concluded.

Event Description

Hip revision surgery performed on (b)(6) 2016 due to subsidence of the stem.The primary surgery was performed on (b)(6) 2016 and the implanted prosthesis consisted of a h-max s stem, a ceramic femoral head and delta tt with pe liner.It was advised that the surgeon might have undersized the stem at the time of primary surgery.Event occurred in (b)(6).

Manufacturer Narrative

By the event description, it appears that stem subsidence due to stem under-sizing (surgical factor) is the root cause of the hip dislocation reported.The check of the dhr of the lot#: of stem involved (lot#: 201516301) did not show any anomalies on the 30 stems manufactured with these lot#.This is the only similar complaint reported on this lot#: (according to our records, 25 stems with this specific lot#: were implanted).Explants were not available to be sent to lima corporate.A pre-revision surgery x-ray (dated on (b)(6) 2016) was provided and then analyzed by our medical consultant for a critical judgment.Medical consultant's remarks are reported here below: "i do not believe that the subsidence of the stem was due to undersizing.On the x-ray (dated on (b)(6) 2016) - shortly before the revision - i see three cerclage wires, fixing a periprosthetic fracture of the proximal femur.This may have occurred before or during the primary procedure.In such a case the surgeon must go for a stem with stable more distal fixation.The h-max stem is not appropriate for such conditions, especially the lateralized version.It relies mainly on a proximal fixation which in this case must have been severely compromised.A modular revision stem would have been indicated in such case".In fact, the surgical technique provided with h-max s stems specifies that these stems have a proximal fixation, not a distal one.According to the above medical judgment, likely cause for stem subsidence and need of revision surgery was a suboptimal choice of initial implant (a different type of stem - with distal fixation - should have been chosen by the surgeon).No indication that the stem itself contributed to the event: event not product related.Pms data: a total of six revision surgeries due to subsidence of h-max s lateralized stems were reported to limacorporate, on a total of 12.338 h - max s lateralized stems marketed ww since 2009 giving a revision rate of 0.049%.According to our investigation, none of these complaints was product - related.Lima corporate will keep monitoring the market to promptly detect any other similar issue.

Event Description

Hip revision surgery performed on (b)(6) 2016 due to subsidence of the h-max s stem originally implanted on (b)(6) 2016.This led to hip dislocation.Patient pain was also reported.According to the info reported, surgeon who performed primary surgery had probably undersized the stem at that time.Event occurred in australia.

• Brand Name: H-MAX S LATERALIZED UNCEMENTED STEM
• Type of Device: H-MAX S LATERALIZED UNCEMENTED STEM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 6735526
• MDR Text Key: 80776820
• Report Number: 3008021110-2016-00119
• 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,Followup
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2020
• Device Model Number: 4251.20.110
• Device Lot Number: 201516301
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention