MAUDE Adverse Event Report: LIMACORPORATE S.P.A. DELTA PROTR.LINER ØINT 28MM #S; PROTRUDED LINERS (UHMWPE X-LIMA + TI6AL4V) I.D. 28MM - SIZE SMALL

Model Number 5886.51.055

Device Problems Device Slipped (1584); Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

No anomaly detected by checking the manufacturing chart of the lot# of the poly liner involved (201705506).This is the first and only complaint received on lot#201705506 on a total of 45 poly liners manufactured with the same lot#.Explants analysis: we received the explants (delta poly liner + femoral head-s dia.28mm; the delta pf cup remained implanted) involved in this intra operative issue.The poly liner underwent a further dimensional check which showed the presence of slight deviation on its external diameters; based on the manufacturing chart, this slight deviation was not present on the liner before placing it into the market: the deformation of the liner was caused by the in vivo use of the device and by the sterilization in autoclave performed after the explantation (high temperatures reached in autoclave cause deformation of the polyethylene).X-rays analysis: post-op x-rays related to the definitive implant were received.A medical opinion on the x-rays states that such "early" dislocation of the liner is probably due to a suboptimal implantation of the cup: analyzing the x-rays, the impression is that not only the liner, but the cup as a whole, dislocated (thesis confirmed by the fact that during the surgery, the cup had to be repositioned).The root cause for dislocation may be found in some insufficient anchoring of the cup.We cannot go back with certainty to the causes of the intra-operative issue.Another possible cause of the event is the presence of soft tissue prevented the correct coupling between liner and cup during surgery.With regard to this, the surgical technique also specifies that "before inserting the definitive articular liner, clean the interior rim of the cup carefully and check that soft tissues will not interfere with definitive liner insertion".Pms data: we are aware of 14 cases of intra-op dislocation/unstable coupling of delta poly liners protruded and a delta acetabular cup, on about (b)(4) delta poly liners belonging to the families(b)(4) sold ww since 2002.All the cases investigated were not product-related.No corrective action planned for this case.Limacorporate will continue monitoring the market to promptly detect any similar issue.This is a final report.

Event Description

Intra-op issue occurred on (b)(6) 2017: during a hip surgery, the poly liner came out from the acetabular cup twice, even after the patient was closed.In order to achieve a good stability, it was necessary to: re-open the patient for removing the poly liner and the femoral head size s dia.28mm; re-position the acetabular cup dia.48mm; implant a new poly liner, with the same size of the one that has to be removed; the new liner was implanted with no difficulties; implant a new femoral head size l dia.28mm.According to the info reported, prolonged surgery time of 4 hours was experienced due to this issue.Event happened in (b)(6).

• Brand Name: DELTA PROTR.LINER ØINT 28MM #S
• Type of Device: PROTRUDED LINERS (UHMWPE X-LIMA + TI6AL4V) I.D. 28MM - SIZE SMALL
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 6885653
• MDR Text Key: 252285086
• Report Number: 3008021110-2017-00082
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 5886.51.055
• Device Lot Number: 1705506
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2017
• 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