MAUDE Adverse Event Report: LIMACORPORATE S.P.A. DELTA POLY LINER PROTRUDED, I.D. 32MM, #M; LPH - MBL

Model Number 5886.51.158

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 09/26/2014

Event Type  malfunction  

Event Description

During a hip surgery dated (b)(6) 2014, the delta poly liner protruded did not find a stable coupling inside a delta spacer (device not marketed in the us); in particular, the liner rotated inside the spacer without finding a complete fixation.The poly liner has a (b)(4) 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 from the spacer and replaced it with another delta poly liner of the same type with success.Surgical time prolonged by 10 minutes.The intra-operative issue occurred in (b)(6).

Manufacturer Narrative

We checked the work cycle of the delta poly liner + (b)(4) ring involved, without finding any dimensional anomaly on the (b)(6) pieces manufactured with the lot # 201408555.(b)(4).We also 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 diameter of the polar peg, which is deformed; in fact, its external diameter in different points goes from 6.98mm to 7.04mm (maximum allowed for this dimension: 7.00mm).This slight deviation, which was not present soon after the manufacturing process of the liner, indicates that the polar peg of the liner could have experienced an unexpected impingement with the inner surface of the spacer when the device was used.The roughness of the returned (b)(4) ring is compliant with specifications.We then performed a functional check with the returned liner and a sample of delta spacer like the one involved in the issue, 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 spacer.We then proceeded with the axial impaction as per surgical technique; after just 2 impactions, the liner completed its conical coupling inside the spacer, and it remained 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 spacer, which prevented the correct coupling between the components during surgery.With regard to this, the delta surgical technique specifies: "before inserting the definitive articular liner, clean the interior rim of the cup/spacer carefully and check that soft tissues will not interfere with definitive liner insertion".Another possible cause is the suboptimal position of the liner inside the spacer during surgery, this could have prevented a correct coupling between the 2 devices.No corrective actions have been planned for this case.We are aware of (b)(6) total cases of 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.(b)(4).All the above cases except 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: DELTA POLY LINER PROTRUDED, I.D. 32MM, #M
• Type of Device: LPH - MBL
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; san daniele del friuli, udine 3303 8; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A.; via nazionale 52; san daniele del friuli, udine 3303 8; IT 33038
• Manufacturer Contact: giulio puppa ; via nazionale 52; san daniele del friuli, udine 33038 ; IT 33038
• MDR Report Key: 4209879
• MDR Text Key: 4984935
• Report Number: 3008021110-2014-00018
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: 112898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2014

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: 07/31/2019
• Device Model Number: 5886.51.158
• Device Lot Number: 201408555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2014
• Initial Date Manufacturer Received: 09/29/2014
• Initial Date FDA Received: 10/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2014
• 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): Hospitalization