MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIVERSAL STEM 115X18MM FLUTED; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Model Number	86-7432
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/29/2021
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
1st stage revision case due to infection.Removal of depuy components.Replaced the components with a s&n femoral nail covered with cement/vancomyocin.2nd stage of revision will be in 3-6 months.
Event or Problem Description
A.Date of implantation.Not sure sorry.B.Lot number: universal stem 115x14mm fluted (867428) and lps xx-sm hinge pin.Refer image uploaded.C.Please confirm if the cement was manufactured by depuy? if yes, please provide the quantity, part and lot numbers of the cement.No styker.
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).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: the concomitant products were identified to be competitor products used in conjunction with the previously reported adverse event.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 no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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: UNIVERSAL STEM 115X18MM FLUTED
• Common Device Name: UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11796230
• Report Number: 1818910-2021-09853
• Device Sequence Number: 14498348
• Product Code: JWH
• UDI-Device Identifier: 10603295217923
• UDI-Public: 10603295217923
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/29/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: 86-7432
• Device Catalogue Number: 867432
• Device Lot Number: 621791
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 05/25/2021; 06/23/2021; 07/26/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/23/2021; 07/07/2021; 07/27/2021
• 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 XSM RT; LPS FEM TO SLEEVE ADAPTER +0; LPS UNIV TIB HIN INS XSM 18MM; LPS XX-SM HINGE PIN; MBT REV TIB TRAY SIZE 4 15MM; MBT TRAY SLEEVE POR M/L 45MM; PFC*SIGMA/OV/DOME PAT 3PEG,41; STRYKER CEMENT; STRYKER CEMENT:6197-1-001/THZ026; STRYKER CEMENT:6197-1-001/THZ026; UNIVERSAL FEM SLV FUL POR 34MM; UNIVERSAL STEM 115X14MM FLUTED; UNIVERSAL STEM 115X18MM FLUTED; LPS DISTAL FEM COMP XSM RT; LPS FEM TO SLEEVE ADAPTER +0; LPS UNIV TIB HIN INS XSM 18MM; LPS XX-SM HINGE PIN; MBT TRAY SLEEVE POR M/L 45MM; UNIVERSAL FEM SLV FUL POR 34MM; UNIVERSAL STEM 115X14MM FLUTED; UNIVERSAL STEM 115X18MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR