MAUDE Adverse Event Report: LIMACORPORATE S.P.A. DELTA PROTRUDED LINER ØINT 36MM #L; PROTRUDED LINERS (UHMWPE X-LIMA + TI6AL4V) I.D. 36MM - SIZE LARGE

Model Number 5886.51.260

Device Problem Patient Device Interaction Problem (4001)

Event Date 10/17/2023

Event Type  Injury  

Event Description

Hip revision surgery performed on (b)(6) 2023, due to infection.The following components got removed: delta-revision-tt acetabular cup ø54mm (product code 5533.38.054, lot #2228713 - ster.(b)(6) ) - product not sold in the us.Delta protruded liner øint 36mm #l (product code 5886.51.260, lot #2221049 - ster.(b)(6)).Bone screw ø6,5 h.20mm (product code 8420.15.010, lot #2312008 - ster.(b)(6)).Bone screw ø6,5 h.25mm (product code 8420.15.020, lot #2313171 - ster.(b)(6)).Bone screw ø6,5 h.45mm (product code 8420.15.060, lot #2310586 - ster.(b)(6)).Bone screw ø6,5 h.50mm (product code 8420.15.070, lot #2202370 - ster.(b)(6)).Bone screw ø6,5 h.60mm (product code 8420.15.090, lot #2114092 - ster.(b)(6)).Competitor's implants were on the femoral side were.It was reported that specimens were taken, however results aren't yet available.A cemented acetabular cup and a competitor's femoral stem were implanted as a temporary spacer while infection is treated.Primary surgery took place on (b)(6) 2023.Patient is a female, 82 years old.Clinical data aren't available.Event happened in australia.

Manufacturer Narrative

Checking the sterilization charts of involved lot #s, no pre-existing anomalies were found on the components manufactured with those lot #s.We submit a final mdr as soon as the investigation is complete.

Manufacturer Narrative

Checking the sterilization charts of the involved lot #s, no pre-existing anomaly was found.Therefore, all the products with these lot #s have been properly sterilized before being placed on the market.Explants analysis devices involved were not available to limacorporate for further analysis.X-rays analysis limacorporate received one x-ray referring to pre-operative revision surgery.The x-ray received - exact date is unknown (the x-ray is dated (b)(6) 2023) - have been evaluated by a medical consultant.Following, the medical consultant comments: "the sent x-ray shows a very extensive reconstruction of the acetabulum.I therefore have doubts this has been a primary.The more that i see some osteolysis at the trochanter.Maybe it was a salvage procedure after severe pelvic fracture? otherwise it must have been a revision.Anyway, an infection after such an invasive procedure in an 82yr old lady is not very surprising.The described revision followed the usual standards for such a case.For sure the implants cannot be blamed for the infection or any other failure".Considering that: check of the sterilization charts highlighted no anomalies on the components manufactured with the involved lot #s; according to the medical consultant "[.] an infection after such an invasive procedure in an 82yr old lady is not very surprising.The described revision followed the usual standards for such a case.For sure the implants cannot be blamed for the infection or any other failure"; we can state that the event was not product related.Pms data according to limacorporate pms data, the revision rate of delta tt revision acetabular cups - belonging to the family codes 5533.38.Xxx - due to infection is (b)(4).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 performed on (b)(6) 2023, due to infection.The following components got removed: delta-revision-tt acetabular cup ø54mm (product code 5533.38.054, lot #2228713 - ster.2300062) - product not sold in the us.Delta protruded liner øint 36mm #l (product code 5886.51.260, lot #2221049 - ster.2200268).Bone screw ø6,5 h.20mm (product code 8420.15.010, lot #2312008 - ster.2300132) bone screw ø6,5 h.25mm (product code 8420.15.020, lot #2313171 - ster.2300132) bone screw ø6,5 h.45mm (product code 8420.15.060, lot #2310586 - ster.2300116) bone screw ø6,5 h.50mm (product code 8420.15.070, lot #2202370 - ster.2200072) bone screw ø6,5 h.60mm (product code 8420.15.090, lot #2114092 - ster.2100290) implants on the femoral side were from a competitor.It was reported that specimens were taken, however results weren't available.A cemented acetabular cup and a competitor's femoral stem were implanted as a temporary spacer while infection is treated.Primary surgery took place on (b)(6) 2023.Patient is a female, 82 years old.Clinical data aren't available.Event happened in australia.

• Brand Name: DELTA PROTRUDED LINER ØINT 36MM #L
• Type of Device: PROTRUDED LINERS (UHMWPE X-LIMA + TI6AL4V) I.D. 36MM - SIZE LARGE
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 18012988
• MDR Text Key: 326630836
• Report Number: 3008021110-2023-00117
• 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: 01/24/2024

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: 5886.51.260
• Device Lot Number: 2221049
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/24/2024
• 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): Other