MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMP VVC INS LG 10MM; KNEE TIBIAL INSERT

Catalog Number	129424610
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).D4- the device catalog number is unknown; therefore, udi is unavailable.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the implant is broken.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? unknown, did the patient require revision surgery or hardware removal? yes, facility name of original implant: (b)(6), was device explanted? true, did patient require revision surgery? true, patient status/ outcome / consequences , was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study unknown, (b)(4).Device property of: none, device in possession of: none by checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed, as the required product/lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected and distributed to approved specifications.Additional complaint information, monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: the device lot number is unknown.Therefore, a device history review could not be performed.  if the lot/serial number becomes available, the record will be re-assessed.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: d4 (lot, udi, expiration date), g4 (pma), h4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d1, d2a, d4 (catalog).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A manufacturing record evaluation was performed for the finished device product 129424610, lot ce7f74000, and no non-conformances / manufacturing irregularities were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot : a manufacturing record evaluation was performed for the finished device product 129424610, lot ce7f74000, and no non-conformances / manufacturing irregularities were identified.
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information, which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained, that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : it was reported that implant break.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device revealed that the lcs comp vvc ins lg 10mm was found broken from the post.Additionally the implant exhibits signs of wear, which may be due to the 16 years it has been implanted in the patient.However, with the information provided is not possible to determine a potential cause at this moment, the mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables e.G.Activity level and use, anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A dimensional inspection was unable to be performed due to post manufacturing damage.A functional evaluation was unable to be performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the lcs comp vvc ins lg 10mm would contribute to the complained device issue.¿ based on the investigation findings, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a manufacturing record evaluation was performed for the finished device product 129424610, lot ce7f74000, and no non-conformances / manufacturing irregularities were identified.

• Brand Name: LCS COMP VVC INS LG 10MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17966792
• Report Number: 1818910-2023-21400
• Device Sequence Number: 20771993
• Product Code: NJL
• UDI-Device Identifier: 10603295024781
• UDI-Public: 10603295024781
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/19/2023

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: 03/11/2013
• Device Catalogue Number: 129424610
• Device Lot Number: CE7F74000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 10/26/2023; 12/04/2023; 12/21/2023; Not provided; 07/12/2024
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 10/26/2023; 12/05/2023; 12/21/2023; 04/18/2024; 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2008
• 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: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male