MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ADAPTER HALL/JACOBS TO LG AO; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71177205
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event or Problem Description
It was reported that before surgery, there was rust on the inner part of the adapter.Adapter was opened over the tray and the entire tray had to be reprocessed because of the rust.Delay form 30 minutes to 1 hour.No confirmation of backup has been received.No impact or injury to patient reported.
Additional Manufacturer Narrative
The associated complaint device was not returned.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: ADAPTER HALL/JACOBS TO LG AO
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9114227
• Report Number: 1020279-2019-03471
• Device Sequence Number: 3587150
• Product Code: HSX
• UDI-Device Identifier: 03596010601681
• UDI-Public: 03596010601681
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71177205
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1