MAUDE Adverse Event Report: LIMACORPORATE S.P.A. DELTA CUP ACCESSORIES; NEUTRAL LINERS (UHMWPE X-LIMA + TI6AL4V) I.D. 32MM - SIZE MEDIUM

Model Number	NEUTRAL LINER
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We checked the manufacturing charts of all the explanted components: delta neutr.Liner øint 32mm #m 5885.51.158 lot# 1406267 - no pre-existing anomaly on the (b)(4) pieces placed on the market with this lot#.Modulus neck s taper b 12/14 code 7590.15.030 lot# 1403514 - no pre-existing anomaly on the (b)(4) pieces placed on the market with this lot#.Modulus mod.Stem ø23 mm code 4310.15.110 lot# 1303564 - no pre-existing anomaly on the (b)(4) pieces placed on the market with this lot#.Fem.Modular head - m ø32mm 5010.42.322 lot# 1481197 - no pre-existing anomaly on the (b)(4) pieces placed on the market with this lot#.We will proceed with further investigations and submit a final mdr once concluded.
Event or Problem Description
Hip revision surgery due to frequent dislocations performed on (b)(6) 2018.Previous surgery performed on (b)(6) 2014.According to the info provided, the surgeon had planned to replace neck and liner to increase stability, but during surgery he was forced to remove also the stem because it was not possible to disengage it from the neck due to an intra-op issue involving the neck extractor (stem, neck and extractor are not marketed in the usa).The explanted components are the following: delta neutr.Liner øint 32mm #m code 5885.51.158 lot# 1406267; modulus neck s taper b 12/14 code 7590.15.030 lot# 1403514; modulus mod.Stem ø23 mm 4310.15.110 lot# 1303564; fem.Modular head - m ø32mm 5010.42.322 lot# 1481197.Components from another manufacturer have then been implanted.Event happened in (b)(6).
Event or Problem Description
Hip revision surgery due to frequent dislocations performed on (b)(6) 2018.Previous surgery performed on (b)(6) 2014.According to the info provided, the surgeon had planned to replace neck and liner to increase stability, but during surgery he was forced to remove also the stem because it was not possible to disengage it from the neck due to an intra-op issue involving the neck extractor (stem, neck and extractor are not marketed in the usa).The explanted components are the following: - delta neutr.Liner øint 32mm #m code 5885.51.158 lot# 1406267.- modulus neck s taper b 12/14 code 7590.15.030 lot# 1403514.- modulus mod.Stem ø23 mm 4310.15.110 lot# 1303564.- fem.Modular head - m ø32mm 5010.42.322 lot# 1481197.Components from another manufacturer have then been implanted.Event happened in japan.
Additional Manufacturer Narrative
Check of the dhr we checked the manufacturing charts of all the explanted components: -delta neutr.Liner øint 32mm #m 5885.51.158 lot# 1406267 - no pre-existing anomaly on the (b)(4) pieces placed on the market with this lot# -modulus neck s taper b 12/14 code 7590.15.030 lot# 1403514 - no pre-existing anomaly on the (b)(4) pieces placed on the market with this lot# -modulus mod.Stem ø23 mm code 4310.15.110 lot# 1303564 - no pre-existing anomaly on the (b)(4) pieces placed on the market with this lot# -fem.Modular head - m ø32mm 5010.42.322 lot# 1481197 - no pre-existing anomaly on the (b)(4) pieces placed on the market with this lot# x-rays analysis: no x-rays images available for a clinical evaluation.Explant analysis: femoral modular head involved in the complaint was returned to limacorporate for further investigation.Visual inspection showed several signs on the femoral head, indicating that the component dislocated and scraped many times against a metal component.We received also the explanted poly liner (product code 5885.51.158, lot #1406267): visual inspection showed a total of n.3 holes on the internal surface, most probably made by the surgeon trying to remove the delta liner from the acetabular cup (liner was well fixed).No scratches and/or wear visible on the external surface.No patient data (bmi, weight, activity level) nor information about cause and type of dislocation were reported to limacorporate.Based on the info received and the investigation performed, an exact root cause of the event could not be reached.However, stating that: · no anomaly was detected by the check of the dhr related to lot#1481197.· all the remaining n.89 items manufactured with the same lot# have been already implanted without receiving any additional complaint.· the liner was well fixed in the acetabular cup we can conclude that the event cannot be classified as product related.Pms data: on the basis of our pms data, occurrence rate for dislocation of femoral modular heads belonging to the family codes 5010.42.(b)(6) is (b)(4).No corrective actions due to this specific case.Limacorporate will keep monitoring the market.Note: pms data refer to the time when the investigation was completed.The final mdr is hereby submitted to proceed with the closure in the fda database.

• Brand Name: DELTA CUP ACCESSORIES
• Common Device Name: NEUTRAL LINERS (UHMWPE X-LIMA + TI6AL4V) I.D. 32MM - SIZE MEDIUM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 8127812
• Report Number: 3008021110-2018-00104
• Device Sequence Number: 1653210
• Product Code: LPH
• UDI-Device Identifier: 08033390041072
• UDI-Public: 08033390041072
• Combination Product (Y/N): N
• PMA/510(K) Number: K112898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• 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): 03/26/2025

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
• Device Model Number: NEUTRAL LINER
• Device Catalogue Number: 5885.51.158
• Device Lot Number: 1406267
• 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: 12/04/2018
• Supplement Report FDA Received Date: 03/27/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown