MAUDE Adverse Event Report: LIMACORPORATE S.P.A. REVISION; UNCEMENTED STEM DIA=18MM - L=140MM

Model Number	REVISION HIP - TI6AL4V
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191); Medical device site infection (4845)
Date of Event	05/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The check of the dhr of the lot# involved (201310669) in the second hip revision surgery showed no pre-existing anomalies on the (b)(4) revision stem manufactured with this lot#.We performed even a check of the sterilization chart of the lot # 201310669: no anomalies on the (b)(4) revision stem manufactured with this lot#.All the (b)(4) revision stems were regularly sterilized before being placed on the market.No other complaints received on this lot#.The check of the dhr of the lot# involved (201305815) showed no anomalies on the (b)(4) revision modular neck manufactured with this lot#.Even for the lot# 201305815 we performed a check of the sterilization chart: no pre-existing anomalies on the (b)(4) revision modular neck manufactured with this lot#.All the (b)(4) revision necks were regularly sterilized before being placed on the market.No other complaints received on this lot#.We will submit a final mdr after completing the investigation on this case.
Event or Problem Description
First hip revision surgery - done about 4 years ago - due to bone fracture.At that time, competitor's products originally implanted (unknown primary implant date) were removed and a revision stem was implanted.During a second hip revision surgery, performed on (b)(6) of 2017 due to infection, surgeon could not separate the neck from the stem.According to the info reported, neck + stem were removed together only by performing an extended trochanteric osteotomy.Surgery completed by inserting cement spacer containing antibiotic.Event happened in (b)(6).
Additional Manufacturer Narrative
Check of the dhr: the check of the dhr of the lot# involved (1310669) in current hip revision surgery showed no pre-existing anomalies on the 40 revision stems manufactured with this lot#.We performed even a check of the sterilization chart of the lot # 1310669 ster.(b)(4): no anomalies on the (b)(4) revision stems manufactured with this lot#.All the 40 revision stems were regularly sterilized before being placed on the market.No other complaints received on this lot#.Furthermore, all the (b)(4) remaining revision stems manufactured with lot#1310669 have been already sold without receiving any additional complaint.The check of the dhr of the lot# involved (1305815) showed no anomalies on the 24 revision modular necks manufactured with this lot#.Even for the lot# 1305815 ster.(b)(4) we performed a check of the sterilization chart: no pre-existing anomalies on the (b)(4) revision modular necks manufactured with this lot#.All the (b)(4) revision necks were regularly sterilized before being placed on the market.No other complaints received on this lot#.Furthermore, all the (b)(4) remaining revision modular necks manufactured with lot#1305815 have been already sold without receiving any additional complaint.Explants analysis: we received the explants for technical analysis.Because the stem and the neck were fused together, it was not possible to perform any dimensional analysis.Other information: germ responsible for infection is unknown.Stating that: - by the check of the manufacturing and sterilization processes, no pre-existing anomaly was detected - we are not aware of any other complaints with lot #s involved - infection occurred 4 years after implantation of the lima corporate prostheses we can hypothesize that root cause of infection was not product related.About the impossibility to remove the neck from the stem: the "seizure" between stem and neck could have been caused by "cold welding" - linked to fretting - occurred at the tapers interface.Fretting is a phenomenon well known in literature, with reference to ti-ti taper connections like the revision one.No anomaly was detected by checking the dhr of the implants involved, confirming that they were released on the market according to internal specifications.Pms data: on the basis of our pms data, we are aware of (b)(4) cases of infection involving revision system on more than 39000 revision systems implanted worldwide, with an occurrence rate of (b)(4).On the basis of our pms data, we are aware of (b)(4) cases of cold-welding involving revision system on more than 39000 revision system implanted worldwide, with an occurrence rate of (b)(4).No corrective actions due to this specific case.Limacorporate will keep the market monitored.Note: this is a final mdr.
Event or Problem Description
Revision surgery of hip prosthesis performed on (b)(6) 2017 due to infection.During surgery, surgeon could not separate the neck from the stem.It was reported that neck (b)(6) lot #1305815 + stem (b)(4) lot #1310669 were removed together only by performing an extended trochanteric osteotomy and surgery was then completed by inserting cement spacer containing antibiotic.According to the information reported, previous revision surgery was performed about 4 years before and was due to bone fracture.At that time, competitor's products originally implanted (unknown primary implant date) were removed and a revision stem was implanted.Event happened in japan.

• Brand Name: REVISION
• Common Device Name: UNCEMENTED STEM DIA=18MM - L=140MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A.; via nazionale,52; 33038 ; IT 33038
• Manufacturer Contact: giulio puppa ; IT
• MDR Report Key: 6700080
• Report Number: 3008021110-2017-00055
• Device Sequence Number: 13774593
• Product Code: LZO
• UDI-Device Identifier: 08033390003889
• UDI-Public: 08033390003889
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

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
• Operator of Device: Health Professional
• Device Model Number: REVISION HIP - TI6AL4V
• Device Catalogue Number: 3814.15.010
• Device Lot Number: 1310669
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2017
• Supplement Report FDA Received Date: 05/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown