MAUDE Adverse Event Report: LIMACORPORATE S.P.A. REVISION; UNCEMENTED STEM DIA=16MM - L=140MM

Model Number	3812.15.010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sterilization records of the devices involved were checked with the following results: - no pre-existing deviation detected on the 28 revision mod.Stems ø16mm product code 381215010, released with lot 2305109, ster.(b)(4).- no pre-existing deviation detected on the 9 delta-one-tt acetab.Cups ø56mm product code 554914560 released with lot 2223058, ster.(b)(4).- no pre-existing deviation detected on the 60 delta angled spacers 20°# l+5 product code 588615520, released with lot 2213348, ster.(b)(4).We will submit a final report upon the conclusion of the investigation.
Event or Problem Description
Hip revision surgery due to infection performed on (b)(6) 2025.The previous surgery took place in (b)(6) 2023 (exact date not known).According to the information received, the following devices were explanted: - revision mod.Stem ø16mm product code 381215010, lot 2305109, ster.(b)(4).- delta-one-tt acetab.Cup ø56mm product code 554914560, lot 2223058, ster.(b)(4).- delta angled spacer 20°# l+5 product code 588615520, lot 2213348, ster.(b)(4).- femoral head (product details are unknown).This event occurred in italy.
Event or Problem Description
Hip revision surgery due to infection performed on (b)(6) 2025.The previous surgery took place in (b)(6) 2023 (exact date not known).It was reported that intra-operative cultures were positive for e.Cloacae.According to the information received, the following devices were explanted: - revision mod.Stem ø16mm product code 381215010, lot 2305109, ster.2300132 - delta-one-tt acetab.Cup ø56mm product code 554914560, lot 2223058, ster.2200309 - delta angled spacer 20°# l+5 product code 588615520, lot 2213348, ster.2200195 - femoral head (product details are unknown) patient has type 2 diabetes, hypertension, hypercholesterolemia.This event occurred in italy.Note: among the involved product codes, only the revision stem is cleared in the usa.
Additional Manufacturer Narrative
The sterilization records of the devices involved were checked with the following results: - no pre-existing deviation detected on the 28 revision mod.Stems ø16mm product code 381215010, released with lot 2305109, ster.2300132 - no pre-existing deviation detected on the 9 delta-one-tt acetab.Cups ø56mm product code 554914560 released with lot 2223058, ster.2200309 - no pre-existing deviation detected on the 60 delta angled spacers 20°# l+5 product code 588615520, released with lot 2213348, ster.2200195 the available information and pre-operative x-rays of the revision surgery (exact date unknown) were analysed by a medical consultant.With reference to the reported infection, he commented that "infection is a complication that happens in a certain percentage of cases.Nobody can be blamed for this except the surgeon did not observe the principles of hygiene." he also noted a possible dislocation of the delta spacer; however, no additional information or evidence of dislocation was received from the complaint source.In conclusion, we cannot determine with certainty the cause of the infection reported, but it does not seem to be product related.Pms data based on company's pms data, we estimate a revision rate of delta one tt cups due to infection of about 0.01% and a revision rate of revision stems/necks due to infection of about 0.02%.No corrective action needed following this complaint.The company will continue monitoring the market to promptly detect any further similar event.

• Brand Name: REVISION
• Common Device Name: UNCEMENTED STEM DIA=16MM - L=140MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale, 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 22847982
• Report Number: 3008021110-2025-00112
• Device Sequence Number: 12876139
• Product Code: KWY
• UDI-Device Identifier: 08033390003865
• UDI-Public: 08033390003865
• Combination Product (Y/N): N
• PMA/510(K) Number: K151739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2026

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: 3812.15.010
• Device Lot Number: 2305109
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 06/03/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown