MAUDE Adverse Event Report: AESCULAP AG COLUMBUS REV F TIBIA OFFSET CEMENTED T3+; KNEE ENDOPROSTHETICS

Model Number	NR076K
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Ambulation or Postural Difficulties (2544); Implant Pain (4561)
Date of Event	07/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with nr076k - columbus rev f tibia offset cemented t3+.It was reported on (b)(6) 2018, that as a result of having the product implanted, the patient has experienced looseness in the implant, pain and difficulty walking, which resulted in a revision surgery.The primary surgery occurred on (b)(6) 2015, and the revision surgery occurred on (b)(6) 2016.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.Cement used: biomet mv bone cement.A revision surgery was necessary.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00455 (400481542 + nr015k).Involved components: nr015k - columbus rev f femur cemented f5r - 51869643.Nr296k - femur extens.Stem 6¿ d18x157mm cemented - 51622420.Nr400k - nut f/femur extens.Stem all sizes neutr.- 52032922.Nr196k - tibia offset stem d18x92mm cemented - 51681838.Nr133m - columbus rev f mc glid.Surf.T3/3+ 16mm - 51885048.
Additional Manufacturer Narrative
Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.The device quality and manufacturing history records (dhr) were checked for all available lot numbers and were within specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.A clear root cause conclusion cannot be drawn due to the non-availability of important information and the device itself.The conclusion from the root cause analysis is that a systematic device deviation is unlikely, since the received complaints are limited to certain health care institutions and their applicants.The participation of the applicants in this deviation scenario cannot be excluded by today.Based on the root cause analysis result no corrective actions have been carried out.As a preventive action we were in contact with the affected health care institutions and applicants in order to reduce the probability of recurrence.The complaints were submitted to aesculap ag as a summary report.In order to examine further actions, all cases from the summary report are processed as vigilance suspicion cases and are continuously monitored.

• Brand Name: COLUMBUS REV F TIBIA OFFSET CEMENTED T3+
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12355678
• Report Number: 9610612-2021-00489
• Device Sequence Number: 3887386
• Product Code: JWH
• UDI-Device Identifier: 04046963338169
• UDI-Public: 4046963338169
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K083772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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: 01/31/2017
• Device Model Number: NR076K
• Device Catalogue Number: NR076K
• Device Lot Number: 51735538A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2018
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NR015K - 51869643; NR133M - 51885048; NR196K - 51681838; NR296K - 51622420; NR400K - 52032922; NR015K - 51869643; NR133M - 51885048; NR196K - 51681838; NR296K - 51622420; NR400K - 52032922
• Outcome Attributed to Adverse Event: Required Intervention