MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XSM 26MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Model Number	1987-27-126
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	06/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Patient¿s previous proximal tibia replacement (2020), continuing to dislocate poly out of prox tibia component.Revision surgery demonstrated prox tibia replacement component was rotated, causing poly insert to dislocate from post.Also when removed, evidence of metal charring in the implant noted, which can lead to metalosis of components/tissue.Was surgery delayed due to the reported event? --> no, action taken when event occurred? --> replaced proximal tibia component, added segmental 25mm component , was procedure successfully completed? --> yes, were fragments generated? --> yes, if yes, were they removed easily without additional intervention? --> unknown, other information: --> metal wear noted , patient status/ outcome / consequences --> yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)?--> inflammation, dislocations, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, if yes, describe --> rotation of component in segmental sleeve caused repeated poly insert dislocations and potential metal breakdown , is the patient part of a clinical study --> unknown, ip-01474037 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).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: the device associated with this device was returned for examination.The photo investigation and examination of the device found evidence of edge loading which confirmed the reported allegation.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: in order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional previous reports against the provided product code/lot code combination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: LPS UNIV TIB HIN INS XSM 26MM
• Common Device Name: LPS AND S-ROM : 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: 15055063
• Report Number: 1818910-2022-13432
• Device Sequence Number: 13929499
• Product Code: KRO
• UDI-Device Identifier: 10603295079453
• UDI-Public: 10603295079453
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 07/19/2022
• 2 Devices were Involved in the Event: 1 2

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: 1987-27-126
• Device Catalogue Number: 198727126
• Device Lot Number: BFI161D
• 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: 07/01/2022
• Supplement Date Received by Manufacturer: 08/10/2022; 09/29/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 08/11/2022; 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HINGED PIN; LPS PROX TIB REPLC COMP XSM; UNK KNEE STEM LPS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 20 YR
• Patient Sex: Male