MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIV FEM HD 28MM +8; PRSTHSS,HIP,SMI-CNSTRND,MTAL/PLYMR, CMNTD

Catalog Number	129937
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/13/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a revision surgery due to pain.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.[(b)(4)].

• Brand Name: UNIV FEM HD 28MM +8
• Common Device Name: PRSTHSS,HIP,SMI-CNSTRND,MTAL/PLYMR, CMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7133559
• Report Number: 1020279-2017-01292
• Device Sequence Number: 16411037
• Product Code: JDI
• UDI-Device Identifier: 03596010087416
• UDI-Public: 03596010087416
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K870128
• 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: 06/11/2012
• Device Catalogue Number: 129937
• Device Lot Number: 02EM08995
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 03/13/2018
• 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: Hospitalization; Required Intervention