MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OXIN P/S FEM LEFT SZ 6; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71421016
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery performed due to persistent pain and stiffness.Insert size increased to size 12.New 29 mm biconvex patella implanted.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.The medical investigation concluded that, based on the limited information provided and without the return of the device for evaluation, the root cause of the reported pain and stiffness cannot be determined.The impact to the patient beyond the revision cannot be concluded.Should additional information becomes available this issue can be re-elevated.No further clinical assessment is warranted at this time.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: GII OXIN P/S FEM LEFT SZ 6
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8940105
• Report Number: 1020279-2019-03208
• Device Sequence Number: 2521392
• Product Code: JWH
• UDI-Device Identifier: 03596010469229
• UDI-Public: 03596010469229
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K962557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2019

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 Catalogue Number: 71421016
• Device Lot Number: 17JM12996
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 11/26/2019
• 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