MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PROTRUDED POLY LINER FOR DELTA HIP PROSTHESIS; LPH, MBL

Model Number 5886.51.260

Device Problems Fitting Problem (2183); Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2014

Event Type  malfunction  

Event Description

During a hip surgery dated (b)(6) 2014, after insertion of the delta poly liner protruded (device marketed in the u.S.) into a delta pf acetabular cup (device not marketed in the u.S.), the poly liner did not find a stable conical coupling inside the cup.Then the surgeon removed the protruded liner and replaced it with a neutral delta poly liner which seated correctly into the same delta pf cup.The event occurred in italy.

Manufacturer Narrative

We checked the work cycle of the delta poly liner involved, without finding any dimensional anomaly on the 55 pieces with this lot number (201315832) released on the market.By our checks, 30 of these liners have been implanted without receiving any other signaling.We then received the liner involved in this intra-operative issue.The device underwent a further dimensional check, which confirmed the absence of dimensional anomalies.We also performed a functional check with this liner and a sample of delta cup, following the indications of the surgical technique (insertion of the liner into the cup/spacer by pushing it with the forefinger, and then impaction of the liner in an axial direction).After inserting the poly liner with the fingers and checking for its correct lodging, we noticed that the liner was quite stable inside the cup sample.We then proceeded with the axial impaction as per surgical technique; after just 2 impactions, the liner completed its conical coupling inside the cup sample, and it remained fully fixed.This test allowed us to confirm that the delta poly liner could perform well during the surgery, after following the indications reported in the surgical technique.We cannot go back to the causes of the intra-operative issue: it's possible that the surgeon did not completely follow the indications for a correct coupling between liner and cup, or maybe the presence of soft tissue into the cup prevented the correct coupling between liner and cup during surgery.With regard to this, the surgical technique also specifies: "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." no corrective actions have been planned for this case.We are aware of 5 total cases of intra-operative instability involving a protruded delta poly liner marketed in the u.S.(model number 5886.50.Xxx-5886.51.Xxx) and a delta cup or delta spacer.About (b)(4) delta poly liners protruded belonging to this family have been marketed worldwide since 2007 so, according to the above pms data, the total occurrence rate of such issue is (b)(4).All the above (b)(4) cases are about an intra-operative instability between a delta poly liner (marketed in the u.S.) and delta cups or delta spacers which are not marketed in the u.S.Limacorporate will keep monitored the market.

• Brand Name: PROTRUDED POLY LINER FOR DELTA HIP PROSTHESIS
• Type of Device: LPH, MBL
• Manufacturer (Section D): LIMACORPORATE S.P.A.; villanova di san daniele del friuli, udi ; IT
• Manufacturer Contact: via nazionale 52; villanova di san daniele del friuli, udi 33038 ; 432945511
• MDR Report Key: 3851181
• MDR Text Key: 4680941
• Report Number: 3008021110-2014-00005
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K112898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/20/2014

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 Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 5886.51.260
• Device Lot Number: 201315832
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/05/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2014
• Initial Date FDA Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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
• Treatment: DELTA PF CUP (NOT MARKETED IN THE U.S.)
• Patient Outcome(s): Hospitalization