MAUDE Adverse Event Report: AESCULAP AG AS UNIVATION XF TIBIA CEMENTED T1 LM; KNEE ENDOPROSTHETICS

Model Number NO162Z

Device Problems Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Discomfort (2330); Implant Pain (4561)

Event Date 12/23/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturer evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap ag that an as univation xf tibia cemented t1 lm (part # no162z) was implanted during a primary procedure performed on (b)(6) 2019.According to the complainant, loosening of the implant occurred which caused discomfort/pain for the patient.There was permanent impairment.Although requested, additional information has not been made available.The adverse event is filed under (b)(4).Involved components: no186z - as univation xf femur cemented f2 lm - lot unknown.

Event Description

Involved components.No186z - as univation xf femur cemented f2 lm - lot unknown.

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.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 4(5)) according to din en iso 14971 is still acceptable.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 product safety case((b)(4)) were initiated.Any action regarding capa will be addressed with this case.

Event Description

The patient underwent a revision procedure on (b)(6) , 2021.Additional involved component: nl470-univation f meniscal comp.T1 rm/lm 7mm - lot # 52502901.

Manufacturer Narrative

Patient harm changed from permanent impairment to revision surgery.

Manufacturer Narrative

Involved components - no186z - as univation xf femur cemented f2 lm - lot 52336996.Nl470 - univation f meniscal comp.T1 rm/lm 7mm - lot 52502901.Investigation results:[updated with lot numbers] 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 (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specifications valid at the time of production.Review of the complaint history revealed that there are no similar complaints against the same lot number(s) with this error pattern.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 4(5)) according to din en iso 14971 is still acceptable.Explanation and rationale /conclusion and root cause: on the basis of the current information and without the complained devices, a clear conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.There are several root causes for implant loosening.It could be possible that there were problems with the cement technique.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Potential sources of faults relating to the cement include: - the processing time of the used cement was exceeded - wrong temperature.- unfavourable storage.- the age of the cement.- wrong handling with the cement.Corrective action: based upon the investigation results, product safety cases (psc)s were opened.

• Brand Name: AS UNIVATION XF TIBIA CEMENTED T1 LM
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12134782
• MDR Text Key: 260475914
• Report Number: 9610612-2021-00497
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 04046964053733
• UDI-Public: 4046964053733
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NO162Z
• Device Catalogue Number: NO162Z
• Device Lot Number: 52340189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NO186Z - LOT UNKNOWN.; NO186Z - LOT UNKNOWN.; PART # NL470 - LOT # 52502901.; PART # NO186Z - LOT # 52336996.; NO186Z - LOT UNKNOWN
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female