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

Model Number 5886.51.260

Device Problems Device Dislodged or Dislocated (2923); Material Protrusion/Extrusion (2979)

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

Event Date 04/11/2014

Event Type  malfunction  

Event Description

During a hip surgery dated (b)(6) 2014, after insertion and impaction of the delta poly liner protruded into a delta tt acetabular cup, the poly liner dislocated (came out) from the cup during the final reduction.The poly liner has a ti6a14v ring on its outer shell; the ring is used to give stability to the conical coupling between liner and cup.Then the surgeon removed the protruded liner and replaced it with a neutral delta poly liner leaving implanted the same delta tt cup.The intra-operative issue occured in (b)(6).

Manufacturer Narrative

We checked the work cycle of the delta poly liner + ti6414v ring and delta tt cup involved, without finding any dimensional anomaly on the pieces released on the market.In detail, a total of 56 protruded liners have been manufactured with this lot # (201305725); by our checks, 38 of these liners have been implanted without receiving any other signaling related to this lot #.We then received the protruded poly liner involved in this intra-operative issue, which underwent a further dimensional check.The check confirmed the absence of dimensional anomalies for all dimensions of the liner except for the external conicity angle, which is over-dimensioned of 0 degrees 20'.No dimensional anomalies also on the returned ti6a14v ring, except for a slight deviation of its roughness.As both these slight deviations were not present before placing the liner on the market, it's very likely that they are due to the use of the liner.We also performed a functional check with this liner and a sample of delta tt cup, following the indications of the surgical technique.After inserting the poly liner with the fingers and checking for its correct lodging, we noticed that the liner was already 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, 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.A possible cause of the issue is the presence of soft tissue/particles between liner and cup, which prevented the correct coupling between the components during surgery.No corrective actions have been planned for this case.We are aware of 6 total cases o intra-operative instability involving a protruded delta poly liner marketed in the us (model # 5886.50.Xxx-5886.51.Xxx) and a delta cup or delta spacer.About 19960 delta poly liners protruded have been marketed worldwide since 2007 so, according the above pms data the total occurrence rate of such issue is 0.03%.All the above cases except this one are about an intra-operative instability between a delta poly liner (marketed in the us) and delta cups or delta spacers which are not marketed in the us.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 ; IT
• Manufacturer Contact: via nazionale 52; villanova di san daniele del 33038 ; 432945511
• MDR Report Key: 3963954
• MDR Text Key: 4562043
• Report Number: 3008021110-2014-00010
• 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: 04/24/2014

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: 05/31/2018
• Device Model Number: 5886.51.260
• Device Lot Number: 201305725
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/24/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2014
• Initial Date FDA Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• 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 TT CUP DIA.54 MM
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR