MAUDE Adverse Event Report: AESCULAP AG AS TIBIA OFFSET STEM D12X52MM CEMENTED; KNEE ENDOPROSTHESES

Model Number	NR191Z
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap ag that a as tibia offset stem d12x52mm cemented.(part # nr191z) was implanted during a left knee revision surgery performed on (b)(6) 2018.According to the complainant, post-operative bone deterioration of femur and tibia occurred.The complaint device has not been returned to the manufacturer for evaluation.An additional medical intervention was required.According to the patient , a revision surgery in the future is likely.Additional information was not provided.The malfunction is filed under aag reference (b)(4).Associated medwatch reports: (b)(4) - nr191z (9610612-2022-00142), (b)(4) - nr291z (9610612-2022-00143), (b)(4) - nr565z (9610612-2022-00144), (b)(4) - nr565z (9610612-2022-00145), (b)(4) - nr611m (9610612-2022-00146), (b)(4) - nr071z (9610612-2022-00147), (b)(4) - nr005z (9610612-2022-00148), (b)(4) - nr400z (9610612-2022-00149).
Additional Manufacturer Narrative
Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.Batch history review: the device history records (dhr) were reviewed for the reported lot number; the device was found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.No similar complaints were identified against the same lot number with a similar reported event.Conclusion: a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.There is no indication of a material defect, manufacturing failure, or design error on the basis of the device history record.For further investigation, examination of the complaint device is required.
Additional Manufacturer Narrative
Additional information: b5 - patient harm updated, patient condition, planned revision date.B7 - patient medical history.Investigation results previously submitted.
Event or Problem Description
Update: the patient provided some additional information including the proposed revision date of 30oct2023.She had been in contact with a newer surgeon in 2019, after the accident; the doctor at that time noted that the implant was "fine".Some recent unspecified diagnostic test results supposedly showed that the stem was broken or disconnected.She is now working with cedars-sinai orthopedic center.The adverse event is filed under aag reference (b)(4).Associated medwatch reports: (b)(4) - nr191z (9610612-2022-00142).(b)(4) - nr291z (9610612-2022-00143).(b)(4) - nr565z (9610612-2022-00144).(b)(4) - nr565z (9610612-2022-00145).(b)(4) - nr611m (9610612-2022-00146).(b)(4) - nr071z (9610612-2022-00147).(b)(4) - nr005z (9610612-2022-00148).(b)(4) - nr400z (9610612-2022-00149).
Additional Manufacturer Narrative
Correction: b5 & b7 - event and patient history update.D6b - revision date.H6 - code updated.
Event or Problem Description
Update: revision surgery was performed on (b)(6)2023; implant had come apart at the post and plate.It was noted that glue had not been the correct type, stated by surgeon.Treatment for 5 years prior to this included bracing, radio frequency ablation procedures, and opiods.
Additional Manufacturer Narrative
Additional information: b6 - codes updated.Investigation results: the complained product was not available for investigation.Results were based upon batch history review and event description.Batch history review: the device quality and manufacturing history records have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered eportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, revision.Conclusion/preventive measures: on the basis of the current information and without the product for investigation, a clear conclusion cannot be drawn.There is no indication for a material defect or manufacturing failure on the basis of the device history records.Despite the additional information provided by the patient (submitted previously), a root cause for the problems mentioned cannot be clearly defined.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 investigation results, a capa is not required.

• Brand Name: AS TIBIA OFFSET STEM D12X52MM CEMENTED
• Common Device Name: KNEE ENDOPROSTHESES
• 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 gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 14456344
• Report Number: 9610612-2022-00142
• Device Sequence Number: 20008596
• Product Code: KRO
• UDI-Device Identifier: 04046963176105
• UDI-Public: 4046963176105
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/19/2024

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: 01/31/2026
• Device Model Number: NR191Z
• Device Catalogue Number: NR191Z
• Device Lot Number: 52216770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2022
• Supplement Date Received by Manufacturer: 10/13/2023; Not provided; 04/19/2024
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 10/24/2023; 04/19/2024; 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female