MAUDE Adverse Event Report: AESCULAP AG COLUMBUS PS FEMORAL COMP.CEMENTED F5L; KNEE ENDOPROSTHESES

Model Number	NN165K
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: reference code nn075k.Device name columbus cr/ps tib.Plateau cemented t3; serial number n/a; batch number 51712737; manufacturing date 06.12.2010.Reference code device name corresponding internal notification number.Nn165k columbus ps femoral comp.Cemented f5l (b)(4).Nn260p plug f/tibial plateau (b)(4).Nn482 columbus patella 3- pegs p2 30x8mm (b)(4).Nn531 columbus psglid.Surf.W/scrw.T3/3+ 12mm (b)(4).Investigation: no products available.Therefore a failure description at the products are not possible.Pictorial documentation there are no pictures available.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.Explanation and rationale unfortunately due to a lack of data and without the product we cannot determine the exact root cause for the mentioned deviation.Corrective action: for this topic (implant loosening) a product safety case (psc) was initiated.
Event or Problem Description
It was reported that there was an issue with a knee implant system.It was reported on 26jul2018, that as a result of having the product implanted, the patient has experienced knee pain, difficulty walking and loosening of the implant which resulted in a revision surgery.The primary surgery occurred on (b)(6) 2011 and the revision surgery occurred on (b)(6) 2012.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.The adverse event is filed under aag reference (b)(4).Involved components: nn165k (columbus ps femur sz 5 left).Nn075k (columbus cr modular tibia sz 3).Nn260p (peek plug f/tibia).Nn482 (columbus pri/rev pe patella 3-pegs p2).Nn531 (columbus ps tibial insert sz 3/3+ 12mm).Cement used: zimmer palacos r radiopaque bone cement.The primary surgery was performed without as technology.Associated medwatches: 2916714-2020-00370; 2916714-2020-00371; 2916714-2020-00372; 2916714-2020-00373; 2916714-2020-00374.

• Brand Name: COLUMBUS PS FEMORAL COMP.CEMENTED F5L
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11602148
• Report Number: 2916714-2020-00370
• Device Sequence Number: 4206324
• Product Code: JWH
• UDI-Device Identifier: 04038653352128
• UDI-Public: 4038653352128
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2021
• Report Date (Section F): 04/01/2021

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: 06/30/2016
• Device Model Number: NN165K
• Device Catalogue Number: NN165K
• Device Lot Number: 51337681
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/26/2018
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2021
• 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: 04/01/2021