MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 56MM 0 DEGREE ACETABULAR LINER; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 08/08/2016

Event Type  Injury  

Event Description

It was reported that patient underwent revision surgery due to instable left tha.Revision surgery consisted of replacement of acetabular liner, acetabular screw(s) and potentially femoral head.

Manufacturer Narrative

The associated complaint device was not returned for evaluation.A clinical investigation concluded that no information was provided that could explain the dislocation.No further clinical assessment is warranted at this time.Without the return of the actual product involved and no product information available, our investigation of this report is inconclusive.If the device or new information is received in the future, this complaint can be re opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: 56MM 0 DEGREE ACETABULAR LINER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 05001 ; SZ 05001
• MDR Report Key: 7154500
• MDR Text Key: 96042776
• Report Number: 1020279-2017-01359
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: No
• 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: UNKNOWN ACETABULAR FIXATION SCREW(S)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR