MAUDE Adverse Event Report: SMITH & NEPHEW, INC GII OVAL RESURFACING PAT 38MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71421038
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/30/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right knee arthroscopy and manipulation due to: pain, stiffness, mechanical symptoms and dystrophic scar tissue.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.Our clinical evaluation noted that the root causes of the pain and instability suffered by this patient were likely long term results from the damage to the knee from the gunshot wound, which resulted in "severe dystrophic bone and deformity" and in multiple knee procedures with some prior to the noted april 2015 implant of s&n product.Noted is that no mention of a "loose hinge and broken hardware" was documented in the operative notes and the current implants are not smith and nephew products.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.The devices were manufactured in 2012, 2013 and 2014.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: GII OVAL RESURFACING PAT 38MM
• 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: 7811387
• Report Number: 1020279-2018-01617
• Device Sequence Number: 18878547
• Product Code: JWH
• UDI-Device Identifier: 03596010485083
• UDI-Public: 03596010485083
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2018

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: 12/13/2024
• Device Catalogue Number: 71421038
• Device Lot Number: 14MM12244
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 11/04/2018
• 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