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

Model Number 5886.51.158

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 11/23/2015

Event Type  Injury  

Manufacturer Narrative

Check of dhr of the poly liner involved (lot number 201505681) did not show any pre-existing anomaly.This is the 1st and only complaint received on this lot #, on a total of (b)(4)components manufactured with this lot #.We are waiting for further information from the complaint source to perform a deeper investigation.After this analysis, we will submit a follow-up emdr.

Event Description

Dislocation of the delta protruded liner from the delta tt cup occurred 1 month after primary surgery.The event occurred in the (b)(6).No further info available at the moment.

Manufacturer Narrative

Check of dhr of the poly liner involved (lot number 201505681) did not show any pre-existing anomaly.This is the (b)(4) complaint received on this lot #, on a total of (b)(4) components manufactured with this lot #.According to our data, at least (b)(4) of these devices were used.We received the x-rays taken pre ((b)(6) 2015) and post ((b)(6) 2015) primary surgery, and pre ((b)(6) 2015) and post ((b)(6) 2015) revision surgery, together with the explanted acetabular liner.The analysis of the available x-rays by a medical expert highlighted that the femoral stem was correctly positioned during primary surgery.The positioning of the liner during primary surgery cannot be assessed from the x-rays, as the liner is made of polyethylene and is therefore not visible radiologically when its titanium ring is still seated inside the cup.The acetabular cup had a correct angle of abduction but appears to have an angle of anteversion of about 0° degrees, where the standard anteversion should be around 15°.The sub-optimal angle of anteversion of the cup should have increased the risk for posterior dislocation of the femoral head; to reduce this risk, it's likely that the surgeon chose to position the protrusion of the poly liner posteriorly during primary surgery.This liner positioning would have increased the "lever arm" on the protrusion of the liner, contributing to its early dislocation from the cup.In addition, the short duration of the liner "in vivo" (1 month) suggests that the protruded liner may have not correctly placed into the acetabular cup at the time of primary surgery.In the pre-op x-rays of revision surgery, taken approximately one month after primary surgery, the liner appears completely dislocated from the cup and the femoral head dislocated from the poly liner.The returned acetabular liner underwent a further dimensional check which confirmed the absence of dimensional anomalies.Only a slight deformation of the poly liner was detected: since the device was released on the market compliant to specification, this slight deformation is due to the "in vivo" use of the liner.According to our pms data, a total of (b)(4) similar cases were reported on post-operative dislocation of delta protruded acetabular liners coupled with delta cups.In both the other (b)(4) cases the devices involved were compliant to specifications; in (b)(4) of this cases the dislocation occurred due to a surgical error, while in (b)(4) a deep analysis was not possible due to lack of information.About (b)(4) protruded liners were sold worldwide since 2007 giving a total occurrence rate of (b)(4).Limacorporate will keep monitoring the market on the reoccurrence of similar events.

Event Description

Post-op dislocation of the delta protruded liner from the delta tt cup occurred 1 month after primary surgery.Primary surgery was performed on the (b)(6) 2015, revision surgery on the (b)(6) 2015 with replacement of liner and femoral head.The event occurred in (b)(6).

• Brand Name: DELTA PROTRUDED LINER
• Type of Device: DELTA PROTRUDED LINER I.D 32MM #M
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, italy (udine) 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, italy (udine) 33038 ; IT 33038
• Manufacturer Contact: giulio puppa ; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 5324057
• MDR Text Key: 34270798
• Report Number: 3008021110-2015-00056
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/25/2015

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 Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: 5886.51.158
• Device Lot Number: 201505681
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/25/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2015
• 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; Required Intervention