MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PROTRUDED LINERS (UHMWPE X-LIMA + TI6AL4V) I.D. 32MM - SIZE LARGE

Model Number 5886.51.160

Device Problem Device Slipped (1584)

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

Event Type  Injury  

Manufacturer Narrative

No pre-existing defects were found by checking the manufacturing charts of lot# 201704978 on a total of (b)(4) delta poly liner dia.32mm manufactured with this lot#.No other complaints received on the same lot#.We will send a final mdr once the investigation will be completed.

Event Description

Intra-operative difficulty experienced in implanting the poly liner code# 5886.51.160, lot# 1704978.According to the info reported, liner kept coming loose even after three attempts done to be impacted it in the cup.Eventually, the liner got to seat correctly in the delta cup and a prolonged surgery time of 5-10 minutes was registered due to this issue.Event happened in (b)(6) on (b)(6) 2017.

• Brand Name: PROTRUDED LINERS (UHMWPE X-LIMA + TI6AL4V) I.D. 32MM - SIZE LARGE
• Type of Device: PROTRUDED LINERS (UHMWPE X-LIMA + TI6AL4V) I.D. 32MM - SIZE LARGE
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale,52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A.; via nazionale,52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer Contact: giulio puppa ; IT
• MDR Report Key: 6950695
• MDR Text Key: 89364577
• Report Number: 3008021110-2017-00092
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5886.51.160
• Device Lot Number: 1704978
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2017
• 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