MAUDE Adverse Event Report: DEPUY IRELAND ATTUNE REV LPS INSRT XSM 14MM; KNEE TIBIAL INSERT

Catalog Number	151760214
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Unspecified Tissue Injury (4559)
Date of Event	11/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11: additional narrative: d4: udi: as the lot number provided (si508390) for the device involved in the event was not valid, the full udi is currently not available.
Event or Problem Description
It was reported that the patient dislocated the lps poly from the tibial base plate.Patient said that she was crossing her legs to put on a sock when the event happened.She said that she had buckling sensations prior to this dislocation.Patient has also had multiple soft tissue surgeries prior to this surgery one being an extension mechanism repair.The surgeon upsized her poly from a 14mm to 23mm.There was no surgical delay.Doi: (b)(6) 2022, dor: (b)(6) 2024, affected side: left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.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 records evaluation (mre) was not perform 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 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: ATTUNE REV LPS INSRT XSM 14MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20918887
• Report Number: 1818910-2024-25325
• Device Sequence Number: 17404157
• Product Code: KRO
• UDI-Device Identifier: 10603295490975
• UDI-Public: (01)10603295490975
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K191779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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 Catalogue Number: 151760214
• Device Lot Number: SI508390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2024
• Supplement Date Received by Manufacturer: 12/24/2024
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 128 KG