MAUDE Adverse Event Report: AESCULAP AG AS UNIVATION XF TIBIA CEMENTED T5 RM; KNEE ENDOPROSTHESES

Model Number	NO160Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/30/2021
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 no160z - as univation xf tibia cemented t5 rm.According to the complaint description, the implant loosened 5 month and 10 days post surgery.Aseptic early loosening of the medial knee hemiprosthesis on the right.Implantation date: (b)(6) 2020.Revision date: (b)(6) 2021.A revision surgery was necessary.Additional information was not provided.Additional patient information is not available.The adverse event is filed under (b)(4).Associated medwatch-reports: 9610612-2021-00349 (400509551 + no183z), 9610612-2021-00348 (400509552 + no160z).Involved components: nl480 - univation f meniscal comp.T5 rm/lm 8mm - lot 52569651.
Additional Manufacturer Narrative
Investigation results: visual investigation: investigation was carried out visually and microscopically.The femoral-as well as the tibial component show no device failure or serious damage.The provided tibial component show bone cement residues on almost the whole intended area/ coated surface.This indicates that a loosening between the bone and bone cement has taken place.Furthermore the bone cement residues from the tibial component shows only a partly good bone anchorage (cement interlock into the bone trabeculae) has taken place.The femoral component shows only partly cement residues on the intended area with only less bone anchorage.The meniscal component is still fixed in the tibial component.The gliding surface shows little imprints and scratches, which probably resulting from third body wear (bone chips and/or bone cement residues).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.The review of risk assessment revealed that the overall risk level (severity 4 (5) x probability of occurrence 2(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.Based on the bone cement texture on the tibial and femoral component (bone cement residues shows only a partly good bone anchorage) and the fact that there is only partical cement adhesive on the femoral component, it could be possible that there were problems with the cement technique (for example too long processing time).Based upon the investigations results a capa is not necessary.
Event or Problem Description
Associated medwatch-reports: 9610612-2021-00349 ((b)(4)+ no183z).9610612-2021-00348 ((b)(4)+ no160z).

• Brand Name: AS UNIVATION XF TIBIA CEMENTED T5 RM
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11769267
• Report Number: 9610612-2021-00348
• Device Sequence Number: 4434069
• Product Code: HRY
• UDI-Device Identifier: 04046964053719
• UDI-Public: 4046964053719
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K131167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 07/28/2021

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: NO160Z
• Device Catalogue Number: NO160Z
• Device Lot Number: 52498758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 07/29/2021
• 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: NL480; NL480
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR