MAUDE Adverse Event Report: LIMACORPORATE S.P.A. H-MAX S LATERAL. FEM. STEM #13 2; H-MAX S LATERALIZING UNCEMENTED STEMS (TI6AL4V + HA) N.13 (MEH-JDI- KWY)

Model Number 4251.20.130

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 09/25/2018

Event Type  Injury  

Manufacturer Narrative

We checked the sterilization chart of the involved lot #s without finding any anomaly, meaning that the components had been correctly sterilized before being placed on the market.We will submit a final mdr once the investigation will be concluded.

Event Description

First stage hip revision surgery due to infection performed on (b)(6) 2018.During this surgery the components have been removed and a cement spacer put in.Previous surgery performed in (b)(6) 2014.The components involved are the following: h-max s lateral.Fem.Stem #13 code 4251.20.130 lot# 1405425 ster.1400148; fem.Modular head - l ø40mm code 5010.42.403 lot# 1385297 ster.1300341; delta-tt acetab.Cup ø54 mm code 5552.15.540 lot# 1405220 ster.1400155; delta liner øint 40mm # large code 5885.42.262 lot# 1480899 ster.1400180.Event happened in (b)(6).

Manufacturer Narrative

Check of the sterilization charts: by checking the sterilization charts of the lot#s of all the components explanted, 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: no x-rays available.Not known if any previous case of infection was experienced by the patient.Conclusion: with the few info available, we cannot go back with certainty to the root cause of the infection reported.A deeper investigation is not possible.According to the check of the sterilization charts, we can ensure that components originally implanted during the surgery performed in october 2014 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.

Event Description

First stage hip revision surgery performed on (b)(6) 2018 due to infection.During this surgery all the components previously implanted in october 2014 have been removed and a cement spacer put in.Details of components explanted on (b)(6) 2018: h-max s lateral.Fem., stem #13, code 4251.20.130, lot#: 1405425, ster.1400148; fem.Modular head, l ø40mm, code 5010.42.403, lot#: 1385297, ster.1300341; delta-tt acetab.Cup, ø54mm, code 5552.15.540, lot#: 1405220, ster.1400155; delta liner øint, 40mm #large, code 5885.42.262, lot#: 1480899, ster.1400180.At the time of first stage revision reporting date, a second stage revision was not yet booked.According to the info received on 13th of november 2018, the second stage revision was performed on (b)(6) 2018 but no info about components implanted during this second stage revision.Event happened in australia.

• Brand Name: H-MAX S LATERAL. FEM. STEM #13 2
• Type of Device: H-MAX S LATERALIZING UNCEMENTED STEMS (TI6AL4V + HA) N.13 (MEH-JDI- KWY)
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, 33038 ; IT 33038
• MDR Report Key: 8000106
• MDR Text Key: 124964738
• Report Number: 3008021110-2018-00091
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 4251.20.130
• Device Lot Number: 1405425
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention