MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIVERSAL FEM SLV FUL POR 34MM; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE FEMORAL ACCESSORY

Model Number	1294-53-226
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/11/2021
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
The patient was revised because the junction between the femoral sleeve and the 18mm stem broke.Loosening was also reported at bone to implant interface.It is believed to be infected causing femoral sleeve to not in-grow.Everything was taken out and re implanted.No delay to surgery reported.Doi: unknown, dor: (b)(6) 2021, left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary =the device associated with this report was not received for examination.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 = review of the attached dhrs did not reveal any anomalies or deviations.
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: d6a, h6 (clinical code).H6 clinical code: appropriate term / code not available (e2402) is used to capture infections (e19).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: UNIVERSAL FEM SLV FUL POR 34MM
• Common Device Name: UNIVERSAL KNEE STEMS AND SLEEVES : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11202018
• Report Number: 1818910-2021-01548
• Device Sequence Number: 2915275
• Product Code: JWH
• UDI-Device Identifier: 10603295026303
• UDI-Public: 10603295026303
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2021

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 Model Number: 1294-53-226
• Device Catalogue Number: 129453226
• Device Lot Number: H22059
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 01/11/2021; 02/23/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 02/01/2021; 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LPS DISTAL FEM COMP XXSM LT; LPS FEM TO SLEEVE ADAPTER +5; LPS SEGMENTAL COMPONENT 25MM; LPS UNIV TIB HIN INS XXSM 12MM; LPS XX-SM HINGE PIN; MBT REVISION CEM TIB TRAY SZ 3; MBT TRAY SLEEVE POR M/L 61MM; UNIVERSAL FEM SLV FUL POR 34MM; UNIVERSAL STEM 75X18MM FLUTED; UNIVERSAL STEM 75X20MM FLUTED; UNKNOWN BONE CEMENT; LPS DISTAL FEM COMP XXSM LT; LPS FEM TO SLEEVE ADAPTER +5; LPS SEGMENTAL COMPONENT 25MM; LPS UNIV TIB HIN INS XXSM 12MM; LPS XX-SM HINGE PIN; MBT REVISION CEM TIB TRAY SZ 3; MBT TRAY SLEEVE POR M/L 61MM; UNIVERSAL FEM SLV FUL POR 34MM; UNIVERSAL STEM 75X18MM FLUTED; UNIVERSAL STEM 75X20MM FLUTED; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR