MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIVERSAL FEM SLV FUL POR 31MM; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE FEMORAL ACCESSORY

Model Number	1294-53-216
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	10/18/2021
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
Today a full noiles construct was revised.The reason for the revision was for aseptic loosening of the existing implants.Doi: unknown, dor: (b)(6) 2021, unknown side.
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 : a manufacturing record evaluation (mre) was not possible because the required lot code was not provided.

• Brand Name: UNIVERSAL FEM SLV FUL POR 31MM
• 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
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12758654
• Report Number: 1818910-2021-24438
• Device Sequence Number: 19871457
• Product Code: JWH
• UDI-Device Identifier: 10603295026273
• UDI-Public: 10603295026273
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2021

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: 1294-53-216
• Device Catalogue Number: 129453216
• 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: 10/18/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: (MFG. AND PRODUCT NAME UNKNOWN).; LPS UNIV TIB HIN INS XSM 12MM; MBT REVISION CEM TIB TRAY S2.5; MBT TRAY SLEEVE POR M/L 29MM; SIGTIBCEMSTM 13X30 1.5/2/2.5/3; SROM NRHFEM W/PIN XSMLFT 66X58; UNIVERSAL FEM SLV FUL POR 31MM; UNIVERSAL STEM 75X14MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown