MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CON INS SZ 3-4 15MM; PRSTHSS,KNEE,PATELLOFEMOROTIBIAL,SM CNSTRND,CEMENTED,POLYMER/METAL/POLYMER

Catalog Number	71420528
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a poly exchange/washout yesterday, doctor was unable to get both size 3-4 15mm constrained inserts to lock into the revision baseplate.One seemed to be damaged while impacting.Surgery was delayed more than 2 hours.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and several attempts have been made to obtain clinical/medical documents to no avail.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.We consider this investigation closed.

• Brand Name: GNS II CON INS SZ 3-4 15MM
• Common Device Name: PRSTHSS,KNEE,PATELLOFEMOROTIBIAL,SM CNSTRND,CEMENTED,POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7597616
• Report Number: 1020279-2018-01105
• Device Sequence Number: 10807788
• Product Code: JWH
• UDI-Device Identifier: 03596010208064
• UDI-Public: 03596010208064
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• 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): 08/08/2018

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 Catalogue Number: 71420528
• Device Lot Number: 17HM18506
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 08/08/2018
• 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