MAUDE Adverse Event Report: LIMACORPORATE S.P.A. H-MAX S UNCEMENTED STEMS (TI6AL4V+HA) N.8; H-MAX S FEMORAL STEM

Model Number 4250.20.080

Device Problems Loose or Intermittent Connection (1371); Scratched Material (3020)

Patient Problem Failure of Implant (1924)

Event Date 07/23/2016

Event Type  Injury  

Manufacturer Narrative

The check of the dhr of the lot # of stem involved (200908631) did not show any pre-existing anomaly on the 10 stems manufactured with this lot #.No other complaints were reported on this specific lot #.We will submit a final mdr once the investigation will be completed.

Event Description

Hip revision surgery done on (b)(6) 2016 due to aseptic loosening of the h-max s stem (model # 4250.20.080, lot # 200908631).According to the info reported, even the liner has been changed during the revision surgery since it has been scratched during the removal of the stem.Event happened in (b)(6).

Manufacturer Narrative

The check of the dhr of the lot # of femoral stem involved (200908631) did not show any pre-existing anomaly on the 10 stems manufactured with this lot #.No other complaints were reported on this lot #.We received the pre-operative x-rays related to the revision surgery and we asked a medical expert opinion on them.According to the medical expert opinion, no sign of implant loosening can be seen from the available x-ray.Only a lucent line, proximally laterally, can be seen on the available x-ray, that alone is not sufficient for a diagnosis of loosening.No further information on this case is available.We did not receive the explanted items or any pictures of them.No information on the clinical conditions of the patient is available.With the available information, a deep investigation is not possible.According to our pms data, we received a total of 4 complaints due to loosening of a h-max s femoral stem (model #4250.20.Xxx-4251.20.Xxx) on a total of 36399 h-max s stems marketed ww since 2009.The specific revision rate is (b)(4).No corrective action planned for this specific case.Limacorporate will keep monitoring the market.

Event Description

Hip revision surgery done on (b)(6) 2016 due to aseptic loosening of the h-max s stem (model # 4250.20.080, lot # 200908631).According to the reported information, even the liner has been revised during the revision surgery since it has been scratched during the removal of the stem.Event happened in (b)(6).

• Brand Name: H-MAX S UNCEMENTED STEMS (TI6AL4V+HA) N.8
• Type of Device: H-MAX S FEMORAL STEM
• 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, udine 33038 ; IT 33038
• Manufacturer Contact: giulio puppa ; via nazionale, 52; villanova di san daniele, 33038 ; IT 33038 ; 2 945511
• MDR Report Key: 6306647
• MDR Text Key: 66661317
• Report Number: 3008021110-2016-00071
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4250.20.080
• Device Lot Number: 200908631
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2015
• 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