MAUDE Adverse Event Report: AESCULAP AG AS TIBIA OFFSET STEM D14X132 CEMENTLESS; KNEE ENDOPROSTHETICS

Model Number	NR184Z
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information or evaluation results become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that there was an issue with columbus knee implant(s).According to the complaint, the patient fell off a ladder and the implants may be revised in the future; the patient is being followed by a physician for any further treatment.The intial implantation was performed on (b)(6) 2018 and the revision was not yet planned or scheduled.He fell off 16 foot ladder.There is now loosening at medial tibia with severe bone splinter pain 3 inches down, medial with pad scuffing - floater is present.Joint is too tight, however, maximum bend is at acceptable range according to current treating doctor.Tibia now reportedly has osteoporosis.Sharp pain both anterior horizontal plant of patella; perhaps smaller thickness pad replacement would fix pressure problem.Patient is extremely bow-legged, so long stem is torqueing tibia with bone pain.The adverse event / malfunction is filed under xc reference (b)(4).Concomitant products: nr142m kir # 52098006, nr466z lot # 52091106, nr077z lot # 52259916, nr436z lot # 52166188, nr006z lot # 52184799, nr400z lot # 52337135.
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.On the basis of the current information and without the product for investigation, a clear conclusion cannot be drawn.At that time we assume that the mentioned problems are not product related.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our 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.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.
Event or Problem Description
No updates.Concomitant products: nr142m kir # 52098006; nr466z lot # 52091106; nr077z lot # 52259916; nr436z lot # 52166188; nr006z lot # 52184799; nr400z lot # 52337135.

• Brand Name: AS TIBIA OFFSET STEM D14X132 CEMENTLESS
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11334224
• Report Number: 2916714-2021-00018
• Device Sequence Number: 10968641
• Product Code: JWH
• UDI-Device Identifier: 04046963176396
• UDI-Public: 4046963176396
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 12/29/2021
• Report Date (Section F): 02/17/2021

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 Model Number: NR184Z
• Device Catalogue Number: NR184Z
• Device Lot Number: 52330185
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/19/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 12/29/2021
• 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: NR006Z; NR077Z; NR142M; NR400Z; NR436Z; NR466Z
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Date Report Sent to FDA: 02/17/2021