MAUDE Adverse Event Report: AESCULAP AG AS COLUMBUS TIB.HEMI-SP.T2/2+ 10MM RM/LL; KNEE ENDOPROSTHESES

Model Number	NR049Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/01/2019
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 nr049z - as columbus tib.Hemi-sp.T2/2+ 10mm rm/llvia information received from mw5099720.According to the complaint description, an adverse event occurred involving her aesculap left knee implant.Patient stated that she had this knee implanted in 2018 and noticed in 2019 that she began having severe pain.Patient stated that her doctor did a bone scan which showed the implant has lifted and become loose.Patient stated her doctor told her the implant will need to come out.There was a permanent impairment.Additional information was not provided nor available / was not available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00342 (b)(4)+ nr475z.
Additional Manufacturer Narrative
Associated medatch report: 9610612-2021-00342 ( 400509442 nr475z).9610612-2021-00341 (400509443 nr049z).Investigation results as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.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.

• Brand Name: AS COLUMBUS TIB.HEMI-SP.T2/2+ 10MM RM/LL
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11749470
• Report Number: 9610612-2021-00341
• Device Sequence Number: 3984735
• Product Code: JWH
• UDI-Device Identifier: 04046963338145
• UDI-Public: 4046963338145
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2021

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: NR049Z
• Device Catalogue Number: NR049Z
• Device Lot Number: 52345948
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 07/16/2021
• 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