MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE PRESSFIT STR STEM20X60MM; KNEE STEMS

Catalog Number	151320060
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Inadequate Osseointegration (2646)
Date of Event	06/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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 patient had a spacer placed for treatment of infection utilizing lps components on the stated date.After the infection appeared to have cleared, the patient was converted uneventfully to a distal femoral replacement on (b)(6) 2023, where the femoral sleeve was left as it seemed well fixed and could not be removed when attempted.Patient presented for follow up this week in the office with pain in femur and surgeon believed the femoral sleeve was now loose.There was a loosening of femoral sleeve and stem.The loosening interface is non-cemented.Patient was scheduled for surgery and the sleeve was found to be loose, but was unable to be removed as the femur had remodeled and the femoral stem could not be extracted without intervention.After removing the femoral components, a cemented stem was placed uneventfully.While it took some time to expose the femur to access and remove the femoral stem, no delay was encountered because of depuy components.The femur was fractured posteriorly during the removal of the components and a cable was placed without issue to address this.The first 4 items listed were placed on 4-13-23, and the last 4 were placed on 11-16-23.Doi: (b)(6) 2023 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: ATUNE PRESSFIT STR STEM20X60MM
• Common Device Name: KNEE STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JJM (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19730675
• Report Number: 1818910-2024-15111
• Device Sequence Number: 8328049
• Product Code: JWH
• UDI-Device Identifier: 10603295043782
• UDI-Public: (01)10603295043782(17)320430(10)D22043643
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

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 Catalogue Number: 151320060
• Device Lot Number: D22043643
• 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: 06/29/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2022
• 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: ATT REV SLV LPS FEM ADP +10; ATTUNE REV LPS INSRT XXSM 12MM; ATUN FEM SLV M/L 30MM FULL POR; CONTROL CABLE W/CABLE SLEEVE; LPS DISTAL FEM COMP XXSM LT; LPS SEGMENTAL COMPONENT 35MM; LPS SEGMENTAL COMPONENT 45MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 105 KG