MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MOD PF REVISION STEM-300MM SZ 19; PRSTHSS,HIP,HEMI,TRNNNBING,FMORL,MTL/POLYACETAL

Catalog Number	71354335
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/04/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an infection occured to the patient time after the device was implanted.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, based on the available information, the root cause for the "loosening" or the "infection" cannot be concluded.Should any relevant clinical/medical information become available this complaint can be re-assessed.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.Product was sterilized according to sterilization release documentation from quality control.Without the actual product involved our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

• Brand Name: MOD PF REVISION STEM-300MM SZ 19
• Common Device Name: PRSTHSS,HIP,HEMI,TRNNNBING,FMORL,MTL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7489441
• Report Number: 1020279-2018-00871
• Device Sequence Number: 144502
• Product Code: JDH
• UDI-Device Identifier: 00885556211540
• UDI-Public: 00885556211540
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2018

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: 09/16/2022
• Device Catalogue Number: 71354335
• Device Lot Number: 12GTM0024B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 05/05/2018
• Supplement Report FDA Received Date: 09/05/2018
• 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: 58 YR