MAUDE Adverse Event Report: LIMACORPORATE S.P.A. H-MAX S LATERALIZING UNCEMENTED STEMS (TI6AL4V + HA) N.14; H-MAX S LATERALIZING STEM

Model Number 4251.20.140

Device Problem Device Slipped (1584)

Patient Problems Pain (1994); Weight Changes (2607)

Event Type  Injury  

Manufacturer Narrative

The check of the dhr of the lot # of the involved femoral stem (lot #201410115) did not show any anomaly on the (b)(4) pieces manufactured with this lot #.No other complaints received on this lot #.We also performed a check of the dhr of the other devices involved in this adverse event (femoral head: code #5010.42.363, lot #201481960; neutral liner: code #5885.51.260, lot #201409801) and no anomaly emerged on the overall number of pieces manufactured with these lot #.No other complaint were received on these lot #.This analysis indicated that the devices were manufactured in compliance to requirements before being placed on the market.It was reported from the complaint source that the patient weight at the time of surgery was (b)(6); bmi index is not known.High patient weight suggests that the patient might have been obese and that high patient weight might have contributed to the event.No further information (photos or x-rays) on this case were available.We did not receive the explanted items and we did not receive any information about the clinical conditions of the patient, so we could not perform a deeper analysis.Therefore, we could not establish if the original stem was undersized or if the clinical conditions of the patient could have contributed to the stem loosening.According to our pms data, a total of (b)(4) complaints were registered about loosening of h-max s stems, on a total of (b)(4) h-max s stems used ww since 2009 (revision rate: (b)(6)).No corrective action planned for this specific case.Limacorporate will continue monitoring the market on the reoccurrence of similar events.

Event Description

On (b)(6) 2014 the patient underwent a first hip revision surgery and the surgeon replaced the prosthesis with a h-max s femoral stem, a ceramic femoral head and a neutral liner.The patient started complaining about thigh pain approximately one year after surgery and underwent the revision surgery on (b)(6) 2016.At the time of the surgery, the patient weight was (b)(6) (no info on height).During the surgery, it was noticed that the stem was very well fixed distally, but was loose proximally.No additional information (photos or x-rays) were available.Event occurred in (b)(6).

• Brand Name: H-MAX S LATERALIZING UNCEMENTED STEMS (TI6AL4V + HA) N.14
• Type of Device: H-MAX S LATERALIZING STEM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale, 52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer Contact: giulio puppa ; via nazionale, 52; villanova di san daniele, 33038 ; IT 33038
• MDR Report Key: 6636082
• MDR Text Key: 77395039
• Report Number: 3008021110-2016-00087
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Model Number: 4251.20.140
• Device Lot Number: 201410115
• Date Device Manufactured: 09/24/2014
• 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