MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RF INTERFIT ACET TH SZ 54; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71336054
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that debridement was performed due to infection.The patient had pain.The products are still implanted.There is no product failure or no loosening.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.[(b)(4)].

• Brand Name: RF INTERFIT ACET TH SZ 54
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6965504
• Report Number: 1020279-2017-00892
• Device Sequence Number: 13777435
• Product Code: MBL
• UDI-Device Identifier: 03596010197559
• UDI-Public: 03596010197559
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K960094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2018

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 Expiration Date: 05/17/2008
• Device Catalogue Number: 71336054
• Device Lot Number: 80412132
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 10/20/2017
• Supplement Report FDA Received Date: 03/13/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention