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.
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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).
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