MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II 7.5MM RESUR PAT 35MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR

Catalog Number	71932637
Medical Device Problem Codes	Mechanical Problem (1384); Unintended Movement (3026)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/26/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a revision surgery due to aseptic loosening and mechanical complications of the device.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, based on the available information, the root cause of the stated ¿aseptic loosening and mechanical complications of the device¿ cannot be concluded and has not been demonstrated in the revision operative note.No current information on this patient¿s status has been provided at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.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.We consider this investigation closed.
Additional Manufacturer Narrative
The device was not evaluated due to no sample was returned for investigation.Investigation results: the associated complaint devices were not returned.The clinical/medical team concluded, based on the available information, the root cause of the stated "aseptic loosening and mechanical complications of the device" cannot be concluded and has not been demonstrated in the revision operative note.No current information on this patient's status has been provided at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.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.We consider this investigation closed.Credit cannot be issued for the devices.

• Brand Name: GEN II 7.5MM RESUR PAT 35MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7351133
• Report Number: 1020279-2018-00337
• Device Sequence Number: 18980629
• Product Code: JWH
• UDI-Device Identifier: 00885556057117
• UDI-Public: 00885556057117
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2018

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: 10/21/2023
• Device Catalogue Number: 71932637
• Device Lot Number: 13KM17203
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 03/05/2018; 03/05/2018
• Initial Report FDA Received Date: 03/19/2018
• Supplement Report FDA Received Date: 06/19/2018; 10/05/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 57 YR