MAUDE Adverse Event Report: LIMACORPORATE S.P.A. REVISION MODULAR NECK H.60MM; REVISION NECK H. 60 MM

Model Number 7515.15.010

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Implant Pain (4561)

Event Date 01/06/2024

Event Type  Injury  

Event Description

Hip revision surgery performed on (b)(6 2024, due to pain.It was reported that the patient was in consistent pain.The following components got explanted: revision modular neck h.60mm (product code 7515.15.010, lot #2013958 - ster.2000338) femoral modular head - l ø36mm (product code 5010.42.363, lot #1980106 - ster.1900099) a 60mm lateralized proximal body and a 36mm medium ceramic femoral head were implanted.The distal stem was left in situ as it was believed that pain was not caused by the femoral stem.Samples were taken to test for infection.Primary surgery took place on (b)(6) 2021.It was a revision of a competitor's implant performed for unknown reason.During it, lima's devices were implanted.It was reported that pain was present after the first revision.Patient is a female, 73 years old.Event happened in australia.

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #2013958, no pre-existing anomaly was found on the 30 devices manufactured with the same lot #.This is the first and only complaint received on this lot #.We submit a final mdr when the investigation is complete.

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #2013958, no pre-existing anomaly was found on the 30 devices manufactured with the same lot #.According to our records, at least 28 out of 30 revision necks with lot #2013958 and ster.2000338 have been implanted and this is the only complaint received on this lot #.Device analysis: items involved were not available to be returned to limacorporate for further analysis.X-rays analysis: limacorporate received one x-ray referring to pre-operative revision surgery.The x-ray received - dated (b)(6) 2023 - has been evaluated by a medical consultant.Following, the medical consultant comments: "from the given information i cannot identify any reason for ongoing pain.The x-ray is insufficient as only a lateral view.Possible reasons could be cup malposition, infection, lumbar (discopathy) etc.".Considering that: check of manufacturing charts highlighted no anomalies on components manufactured with lot #2013958; according to the received information, the patient was in consistent pain since the previous surgery; according to the medical consultant the reason for the pain cannot be determined based on the available information, given that "possible reasons could be cup malposition, infection, lumbar (discopathy) etc."; we cannot determine the root cause of the event, still we can state that the event was not product related.Pms data: according to limacorporate pms data, the revision rate of revision standard modular necks - belonging to the family codes 7515.15.0xx - due to pain is 0.01%.Based on the root cause analysis performed and according to the relevant pms data, no corrective actions are required for this specific case.Limacorporate continues monitoring the market to promptly detect any further similar issue.Note: this is a final mdr.

Event Description

Hip revision surgery performed on (b)(6) 2024, due to pain.It was reported that the patient was in consistent pain.The following components got explanted: revision modular neck h.60mm (product code 7515.15.010, lot #2013958 - ster.2000338).Femoral modular head - l ø36mm (product code 5010.42.363, lot #1980106 - ster.1900099).A 60mm lateralized proximal body and a 36mm medium ceramic femoral head were implanted.The distal stem was left in situ as it was believed that pain was not caused by the femoral stem.Samples were taken to test for infection, but results weren't accessible.Previous surgery took place on (b)(6) 2021.It was a revision of a competitor's implant performed for unknown reason.During it, lima's devices were implanted.It was reported that pain was present after that first revision.Patient is a female, 73 years old.Event happened in australia.

• Brand Name: REVISION MODULAR NECK H.60MM
• Type of Device: REVISION NECK H. 60 MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 18526696
• MDR Text Key: 333041636
• Report Number: 3008021110-2024-00004
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K151739
• 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: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 7515.15.010
• Device Lot Number: 2013958
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/17/2024
• 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