MAUDE Adverse Event Report: AESCULAP AG UNIVATION F MENISCAL COMP.T2 RM/LM 9MM; KNEE ENDOPROSTHESES

Model Number	NL483
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Disorder (2373); Ambulation or Postural Difficulties (2544)
Date of Event	03/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).When additional information, or investigation results become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that there was an issue with an issue knee implant, left side.Initially, an orthoscopic procedure was performed on (b)(6) 2015.A partial knee replacement was done on (b)(6) 2016.Multiple office visits made because of severe pain.The patient continued to experience pain and consulted another surgeon.A new doctor ordered a 3d bone scan, and it was noted that the components were loose.A revision surgery was necessary.The patient underwent a full knee revision on (b)(6) 2017.The patient was unable to walk without a limp, and does not have full mobility of the knee due to continuous surgeries and scar tissue.The patient was also unable to return to work.The adverse event is filed under xc reference: (b)(4).Involved components: no186z (as univation xf femur cemented f2 lm); no163z as univation xf tibia cemented t2 lm); nl483 (univation f meniscal comp.T2 rm/lm 9mm).Associated medwatches: 2916714-2020-00646; 2916714-2020-00702.
Additional Manufacturer Narrative
B5, b6, b7 updated: extensive medical history provided and reviewed.E1 - updated reporter.Investigation results: to date there is no device available for investigation.Therefore, no investigation possible.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.The current failure rate is within the risk analysis and therefore acceptable.Conclusion and measures / preventive measures: on the basis of the current information and without the product for investigation, a clear conclusion can not be drawn.There is no indication for a material defect, manufacturing failure or design error on the basis of the device history record.For further investigations we need the product for examination.Based on the investigations and results of the 8d report a capa is not necessary.
Event or Problem Description
Update: (b)(6) 2016 procedure - left knee medial unicompartmental arthroplasty.Normal operative course.(palacos bone cement).(b)(6) 2017 preop dx: failed unicompartmental total knee (partial knee) - nickel allergy noted.Indications: significant stiffness and pain, degenerative changes on the other side and patient has requested conversion to a total knee arthroplasty.History: conservative pain treatments have failed; steroid injection in the office with temporary relief; x-ray results showed no obvious signed of loosening, wear or failure.Procedure: revision of left knee; removal of previous knee implant without significant bone loss; replaced with non-aesculap products.3/26-3/28/19 hospital admission for prosthesis pain (imaging order.Diagnosis - possible infection/inflammatory reaction due to internal prosthetic device, implant, and/or graft) - 2nd bone scan.The patient is currently unable to walk without a limp and does not have full mobility of her knee due to continuous surgeries and scar tissue.The patient is unable to return to work.Associated medwatch: 2916714-2020-00646, 2916714-2020-00702, 2916714-2020-00703.

• Brand Name: UNIVATION F MENISCAL COMP.T2 RM/LM 9MM
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10907712
• Report Number: 2916714-2020-00703
• Device Sequence Number: 19637666
• Product Code: JWH
• UDI-Device Identifier: 04046963080471
• UDI-Public: 4046963080471
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2020
• Report Date (Section F): 12/10/2020

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: No Information
• Device Expiration Date: 04/01/2019
• Device Model Number: NL483
• Device Catalogue Number: NL483
• Device Lot Number: 52030895
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/18/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 12/10/2020
• 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
• Patient Age: 59 YR
• Patient Weight: 93
• Date Report Sent to FDA: 12/10/2020