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

Model Number	SUNFIT TH 53
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Replacement of a sunfit th 53 implanted (b)(6) 2017.Patient had increased pain and discomfort.

• Brand Name: SUNFIT TH DUAL MOBILITY ACETABULAR CUP
• Common Device Name: DUAL MOBILITY ACETABULAR CUP - METAL BACK - UNCEMENTED
• Manufacturer (Section D): SERF; 85 avenue des bruyeres; decines, 69150 ; FR 69150
• MDR Report Key: 7956293
• Report Number: 3008668801-2018-00002
• Device Sequence Number: 1311459
• Product Code: LZO
• UDI-Device Identifier: 03662200005437
• UDI-Public: 03662200005437
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/03/2018

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
• Operator of Device: Health Professional
• Device Model Number: SUNFIT TH 53
• Device Catalogue Number: RM50200053
• Device Lot Number: 1701187A
• Was Device Available for Evaluation?: No
• Device Age: 1 YR
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 10/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR