MAUDE Adverse Event Report: LIMACORPORATE S.P.A. H-MAX S LATERAL. FEM. STEM #8; H-MAX S LATERALIZING UNCEMENTED STEMS (TI6AL4V + HA) N.8 (MEH-JDI-KWY)

Model Number 4251.20.080

Device Problems Loss of or Failure to Bond (1068); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 08/17/2018

Event Type  Injury  

Manufacturer Narrative

We will submit a final mdr once the investigation will be concluded.

Event Description

Hip revision surgery due to infection and subsequent loosening of the femoral implant, performed on (b)(6) 2018.Previous surgery took place on (b)(6) 2017.During previous surgery the following components had been implanted: h-max s lateral.Fem.Stem #8 code 4251.20.080 lot# 1302247, ster.1300337; fem.Modular head - l ø40mm code 5010.42.403 lot# 1580446, ster.1500120; delta-tt acetab.Cup ø56 mm for code 5552.15.560 lot# 1700771, ster.1700078; delta liner øint 40mm # large code 5885.42.262 lot# 1780169, ster.1700054.The femoral side of the implant has been replaced during revision surgery: revision stem (code 3812.15.010), neck with screw (code 7515.15.110) and femoral head (code 5010.42.401) have been implanted.Event happened in (b)(6).

Event Description

Hip revision surgery performed on (b)(6) 2018 due to infection and subsequent loosening of the femoral implant.Previous surgery took place on (b)(6) 2017.During previous surgery the following components have been implanted: h-max s lateral.Fem.Stem #8 code 4251.20.080 lot# 1302247, ster.1300337; fem.Modular head - l ø40mm code 5010.42.403 lot# 1580446, ster.1500120; delta-tt acetab.Cup ø56 mm for code 5552.15.560 lot# 1700771, ster.1700078; delta liner øint 40mm # large code 5885.42.262 lot# 1780169, ster.1700054.The femoral side of the implant has been replaced during revision surgery: revision stem (code 3812.15.010), neck with screw (code 7515.15.110) and femoral head (code 5010.42.401) have been implanted on (b)(6) 2018.Event happened in australia.

Manufacturer Narrative

Check of sterilization charts: by checking the sterilization charts of the lot#s of all the components explanted on (b)(6) 2018, no anomaly was found on the overall number of components, thus confirming that components had been properly sterilized before being placed on the market.Explants analysis: explants were not available to be returned to limacorporate for further analysis.According to the info reported, explants were disposed of by the hospital.X-rays analysis: limacorporate received only 1 x-ray (whose exact date unknown) referring to pre-op revision surgery and the following additional info: germ responsible for infection is unknown.The modular femoral head 5010.42.403 (#l) originally implanted was replaced by a modular femoral head 5010.42.401 (#s) during the revision surgery to ensure correct implant tensioning/biomechanical parameters since the h-max s stem originally implanted was replaced with a lima revision stem and a 60mm neck was used.The only x-ray received was evaluated by a lima medical consultant.Following the medical evaluation: "on the x-ray provided i do not see any sign of loosening.However, as you informed revision has been because of infection one year after implantation.In such case all implants, loose or not, need to be removed anyway, according to existing guidelines.There is no information how it was done (one stage? two stage? only one component? etc.)".Conclusion: based on the info reported, we do not know if the revision surgery was performed in one or two stages.We know that certainly - on the femoral side - the h-max s stem and femoral head originally implanted were both replaced during the revision surgery performed on (b)(6) 2018.No info about a possible replacement of the acetabular components.With the few info available (no clinical info about previous infection cases reported by the patient), we cannot go back with certainty to the root cause of the infection reported.According to the check of the sterilization charts, we can ensure that components originally implanted on (b)(6) 2017 had been properly sterilized before being placed on the market.Case not product related.Pms data: we are aware of a total of 5 cases of infection involving a h-max s stem (standard + lateralized) belonging to the families 4250.20.Xxx-4251.20.Xxx on a total of more than 50300 h-max s stems sold ww from 2009.Specific revision rate is very low (b)(4).No corrective action for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.

• Brand Name: H-MAX S LATERAL. FEM. STEM #8
• Type of Device: H-MAX S LATERALIZING UNCEMENTED STEMS (TI6AL4V + HA) N.8 (MEH-JDI-KWY)
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 7994014
• MDR Text Key: 124660218
• Report Number: 3008021110-2018-00090
• Device Sequence Number: 0
• Product Code: MEH
• 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
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 4251.20.080
• Device Lot Number: 1302247
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention