MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II 7.5MM RESUR PAT 32MM; PRSTHSS,KNEE,PTLLOFMROTIBL,SMI-CNSTRND,CMNTD,PLYMER/METAL/POLYMER

Catalog Number	71932636
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/03/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented excessive arthrofibrosis of right knee resulting in severe limited range of motion and development of scar tissue resulting in a closed manipulation.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and it was reported that a revision surgery was performed due to excessive lack of motion, pain and infection.The exact cause of the reported infection could not be determined based solely on the information provided.It was further reported the patient presented arthrofibrosis of the right knee with severe limited range of motion and development of scar tissue resulting in a closed manipulation.Arthrofibrosis is a known possible complication after surgical intervention.Although the s&n devices cannot be excluded as to have caused or contributed to the reported event.The explanted device was destroyed.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time and the patient impact beyond the reported arthrofibrosis cannot be determined.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.

• Brand Name: GEN II 7.5MM RESUR PAT 32MM
• Common Device Name: PRSTHSS,KNEE,PTLLOFMROTIBL,SMI-CNSTRND,CMNTD,PLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8525396
• Report Number: 1020279-2019-01602
• Device Sequence Number: 16843679
• Product Code: JWH
• UDI-Device Identifier: 00885556056721
• UDI-Public: 00885556056721
• 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): 10/29/2019

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: 01/26/2026
• Device Catalogue Number: 71932636
• Device Lot Number: 16AM19244
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 10/29/2019
• 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: Other; Required Intervention