MAUDE Adverse Event Report: SERF SUNFIT TH DUAL MOBILITY ACETABULAR CUP; DUAL MOBILITY ACETABULAR CUP - METAL BACK - UNCEMENTED

Model Number SUNFIT TH 59

Device Problems Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 12/14/2017

Event Type  Injury  

Event Description

Primary implantation (b)(6) 2014 with sunfit th 59 and ci 59/28 e with omnilife science stem and head.Patient presented with pain with episodes of clicking an clacking.The revision was on (b)(6) 2017.

• Brand Name: SUNFIT TH DUAL MOBILITY ACETABULAR CUP
• Type of Device: DUAL MOBILITY ACETABULAR CUP - METAL BACK - UNCEMENTED
• Manufacturer (Section D): SERF; 85 avenue des bruyères; décines, 69150 ; FR 69150
• Manufacturer (Section G): SERF; 85 avenue des bruyères; décines, 69150 ; FR 69150
• Manufacturer Contact: jean-luc aurelle ; 85 avenue des bruyères; décines, 69150 ; FR 69150
• MDR Report Key: 8412248
• MDR Text Key: 138529504
• Report Number: 3008668801-2019-00001
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SUNFIT TH 59
• Device Catalogue Number: RM50200059
• Device Lot Number: 1206378A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR