MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OXINIUM FEM SIZE 4 LEFT; PRSTHSIS,KNEE,PATLLFEMOROTIBIL,SMICONSTRAIND,CMENTD,POLYMR/METAL/POLYMER

Catalog Number	71420134
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/24/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to arthrofibrosis.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.A review of the complaint history revealed no prior complaints for the listed lots.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Our clinical/medical team concluded: arthrofibrosis is a condition that sometimes occurs in a knee joint that has recently been injured.Risk factors for arthrofibrosis include replacement knee surgery and arthroscopic surgery.Based on the information provided and without the return of the explant for analysis the root cause of the loosening component and arthrofibrosis cannot be concluded.However, the patient falls prior to the revision could not be ruled out as contributing factors to the reported event.The patient impact beyond the reported revision cannot be determined.No further clinical assessment is warranted at this time.Without the actual products involved, our investigation cannot proceed.If the devices 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: GII OXINIUM FEM SIZE 4 LEFT
• Common Device Name: PRSTHSIS,KNEE,PATLLFEMOROTIBIL,SMICONSTRAIND,CMENTD,POLYMR/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7921268
• Report Number: 1020279-2018-01961
• Device Sequence Number: 11176005
• Product Code: JWH
• UDI-Device Identifier: 03596010430144
• UDI-Public: 03596010430144
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K962557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2019

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: 01/04/2020
• Device Catalogue Number: 71420134
• Device Lot Number: 10AM02259
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 09/29/2018
• Supplement Report FDA Received Date: 04/30/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 59 YR