MAUDE Adverse Event Report: AESCULAP AG VEGA PS+ GLIDING SURFACE T2/2+ 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	NX220
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Implant Pain (4561); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.The device history records (dhr) were reviewed for all available lot numbers; the devices were found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Event or Problem Description
It was reported to aesculap inc.That an vega knee implant system, comprised of the following components, vega system ps femur f5n left (part #nx011z) (ref.Associated mdr id 2916714-2020-00536), vega system tibia obturator 12mm t1-t3+ (part # nn261z) (ref.Associated mdr id 2916714-2020-00537), a vega system ps tibia plateau t2, cemented implant (part # nx053z) (ref.Associated mdr id 2916714-2020-00538), and a vega system ps+ gliding surface implant 10mm t2/t2+ (part # nx220), was implanted during a primary surgery performed on (b)(6) 2015.According to the complainant, following the primary surgery, the patient experienced knee pain, swelling, difficulty walking, and loosening & instability of the implant, which resulted in a revision surgery being performed on (b)(6) 2018.The cement used during the primary surgery is unknown.No known adverse patient effects occurred as a result of the revision surgery.The complaint device is not available to be returned to the manufacturer for evaluation.Additional information has been requested, but has not been made available.The adverse event / malfunction is filed under aag reference (b)(4).Involved components: nx011z - vega system ps femur f5n left lot # 52009719, nn261z - vega system tibia obturator 12mm t1-t3+ lot # 52150497, nx053z - vega system ps tibia plateau t2, cemented implant lot # 52142575, nx220 - vega system ps+ gliding surface implant 10mm t2/t2+ lot # 52119655.

• Brand Name: VEGA PS+ GLIDING SURFACE T2/2+ 10MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10803605
• Report Number: 2916714-2020-00539
• Device Sequence Number: 3773410
• Product Code: JWH
• UDI-Device Identifier: 04046963811181
• UDI-Public: 4046963811181
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/06/2020
• Report Date (Section F): 11/06/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: NX220
• Device Catalogue Number: NX220
• Device Lot Number: 52119655
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/27/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/27/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2020
• 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: Required Intervention
• Date Report Sent to FDA: 11/06/2020