MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II 7.5MM RESUR PAT 35MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71932637
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Loose patella was reason for revision.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, it was reported this patient was revised due to loosening.However, no clinical relevant documents were provided to conduct a thorough medical assessment.The surgeon suspected sheer forces disrupted the fixation and loosened the patella.The explanted component will not be returned.No further clinical/medical assessment is warranted at this time.The impact to the patient beyond the revision cannot be determined.This complaint will be re-evaluated if more information becomes available.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 part revealed no prior complaints for the listed batch/failure mode.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: GEN II 7.5MM RESUR PAT 35MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7653962
• Report Number: 1020279-2018-01257
• Device Sequence Number: 1064893
• Product Code: JWH
• UDI-Device Identifier: 00885556057117
• UDI-Public: 00885556057117
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2018

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: 71932637
• Device Lot Number: 17CM07236
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 07/01/2018
• Supplement Report FDA Received Date: 09/13/2018
• 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