MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIVERSAL STEM 75X22MM FLUTED; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Model Number	86-7420
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	07/28/2021
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 to address knee and instability.Surgeon opted for surgery to revise tibia, removing tray stem and sleeve.Replaced with a thick tray, bigger sleeve, stem and new poly.Surgery was successful.It was reported that the patient had revised in 2018 with a thicker poly (thickest available).No surgical delay.Doi: (b)(6) 2021 dor: (b)(6) 2021 left knee.
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.
Event or Problem Description
It was stated that the patient was revised in 2018 with a thicker poly (thickest available).Patient complaining of pain in knee and not feeling stable.Surgeon opted for surgery to revise tibia, removing tray stem and sleeve.Replaced with a thick tray, bigger sleeve, stem and new poly to gain better balance.Surgery was successful.

• Brand Name: UNIVERSAL STEM 75X22MM 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: 12338579
• Report Number: 1818910-2021-18130
• Device Sequence Number: 17249595
• Product Code: JWH
• UDI-Device Identifier: 10603295217862
• UDI-Public: 10603295217862
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 07/28/2021

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 Model Number: 86-7420
• Device Catalogue Number: 867420
• Device Lot Number: 419275
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 09/03/2021
• 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: MBT REVISION CEM TIB TRAY S2.5; MBT TRAY SLEEVE POR M/L 37MM; TC3 RP TIBIAL INSERT S4,30.0; UNIVERSAL STEM 75X22MM FLUTED; MBT REVISION CEM TIB TRAY S2.5; MBT TRAY SLEEVE POR M/L 37MM; TC3 RP TIBIAL INSERT S4,30.0; UNIVERSAL STEM 75X22MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR