MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 32MM X 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71339556
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/03/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The associated complaint devices were not returned.Without the actual products involved and no device information, our investigation cannot proceed.If the devices are received or new information is provided in the future, this complaint can be re-opened.No further actions are being taken at this time.Based on this investigation, the need for corrective action is not indicated.We consider this investigation closed.
Event or Problem Description
It was reported that a revision surgery was performed to a patient to replace the liner and the femoral head due to continuous dislocations.

• Brand Name: R3 0 DEG XLPE ACET LNR 32MM X 56MM
• Common Device Name: 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; 38116; memphis TN
• Manufacturer Contact: sarah freestone ; 101 hessle road; hu3 2bn; hull ; UK ; 0447940038246
• MDR Report Key: 7803906
• Report Number: 1020279-2018-01560
• Device Sequence Number: 7061401
• Product Code: MBL
• UDI-Device Identifier: 03596010615251
• UDI-Public: 03596010615251
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2018

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 Expiration Date: 07/14/2018
• Device Model Number: 71339556
• Device Catalogue Number: 71339556
• Device Lot Number: 08GM11827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 07/23/2018; 07/23/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 08/21/2018; 11/04/2018
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2008
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71331856PN: 71336500PN: 71309011
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male
• Patient Weight: 190 KG