MAUDE Adverse Event Report: LIMACORPORATE S.P.A. DELTA-TT ACETABULAR CUP Ø54 MM; ACETABULAR CUPS (TI6AL4V) DIA. 54MM FOR LINER SIZE LARGE

Model Number 5552.15.540

Device Problems Inadequacy of Device Shape and/or Size (1583); Positioning Problem (3009)

Patient Problems Irritation (1941); Pain (1994)

Event Date 08/13/2020

Event Type  Injury  

Manufacturer Narrative

By checking the dhr of the lot #1204382, no pre-existing anomaly was detected on all the components manufactured with this lot #.This is the first and only complaint received on this lot number.We will submit a final mdr once the investigation will be completed.

Event Description

Revision surgery due to pain performed on (b)(6) 2020.It was reported irritation of psoas muscle secondary to cup positioning incorrectly.According to the complaint source, it was also noted that the cup size was too big.The following items were explanted: fem.Modular head - m ø32mm (product code 5010.42.322, lot# 1481807 - ster.1400283).Delta-tt acetab.Cup ø54 mm for (product code 5552.15.540, lot# 1204382 - ster.1200148).Delta neutr.Liner øint 32mm #l (product code 5885.51.160, lot# 1409022 - ster.1400235).Bone screw ø6,5 h.20mm (product code 8420.15.010, lot# 1406913 - ster.1400204).Explants were replaced by similar components from other manufacturers.Primary surgery performed on (b)(6) 2015.The patient is a female born (b)(6).Event happened in (b)(6).

Manufacturer Narrative

By checking the manufacturing charts of the involved lot #1204382, no pre-existing anomaly was found on a total of 10 items manufactured with the same lot #.According to our records, at least 4 out of 10 delta tt acetabular cups with lot #1204382 - ster.1200148 have been implanted and this is the only complaint received on this lot #.Explants were not available to be returned to hq for further analysis.X-rays analysis limacorporate received one x-ray referring to pre-operative revision surgery.The x-ray received - dated 04/04/2019 - have been evaluated by a medical consultant.Following, the medical consultant comments: "the cup has been placed incorrectly (too vertical, too much anteverted and because of the positioning it is also too large).There is only an ap-xray but from that it may be concluded the "free" anterior portion also irritated the iliopsoas tendon.Such the surgeon is to be blamed for incorrect use of an otherwise correct implant.Revision has been required".Considering that: · check of the manufacturing charts highlighted no anomalies on the total number of components manufactured with lot #1204382; · according to the reported information there was "irritation of psoas muscle secondary to cup positioning incorrectly" and "it was also noted that the cup size was too big"; · according to the medical consultant "the cup has been placed incorrectly [.] the "free" anterior portion also irritated the iliopsoas tendon"; we can classify the event as surgical factor related.Pms data.According to limacorporate pms data, revision rate of delta tt acetabular cups - belonging to the family codes 5552.15.Xxx - due to pain is 0.01%.Based on the root cause analysis performed and according to the relevant pms data, no corrective actions required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.Note: this is a final mdr.

Event Description

Hip revision surgery of the delta-tt acetabular cup ø54 mm for (product code 5552.15.540, lot #1204382 - ster.1200148) performed on august 13th, 2020, due to pain.It was reported irritation of psoas muscle secondary to cup positioning incorrectly.According to the complaint source, it was also noted that the cup size was too big.The following items were explanted: · delta-tt acetabular cup ø54 mm for (product code 5552.15.540, lot #1204382 - ster.1200148) · femoral modular head - m ø32mm (product code 5010.42.322, lot# 1481807 - ster.1400283) · delta neutral liner øint 32mm #l (product code 5885.51.160, lot# 1409022 - ster.1400235) · bone screw ø6,5 h.20mm (product code 8420.15.010, lot# 1406913 - ster.1400204) explants were replaced by similar components from other manufacturers.Primary surgery took place on (b)(6) 2015.The patient is a female, 55 years old.Event happened in new zealand.

• Brand Name: DELTA-TT ACETABULAR CUP Ø54 MM
• Type of Device: ACETABULAR CUPS (TI6AL4V) DIA. 54MM FOR LINER SIZE LARGE
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 10572052
• MDR Text Key: 215924104
• Report Number: 3008021110-2020-00069
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K112898
• 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: 12/21/2021

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: 5552.15.540
• Device Lot Number: 1204382
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/29/2021
• 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