MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIVERSAL STEM 115X14MM FLUTED; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Model Number	86-7428
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Discomfort (2330)
Date of Event	04/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 underwent primary unicompartmental knee replacement on (b)(6) 2018.Patient presented with a fracture of the tibial plateau - at this point the unicompartmental knee was revised to a pfc tc3 rp.Patient has reported ongoing pain and discomfort from time of revision procedure.Bone scans indicate increased uptake around the tip of the tibial stem and around the resurfaced patella.A decision was made to revise some/ all of the tc3.On opening the knee, all the components were found to be well fixed.Extensive scarring/ scar tissue was found around the inferior pole of the patella component - this was excised.The tibial tray and stem were removed leaving the tibial sleeve in situ.The sleeve was again checked to ensure it was well fixed.An alternative tray was implanted into the fixed tibial sleeve, but this time without a stem.The view being that the sleeve is well fixed and the load would transfer through the sleeve - the stem would then not be required and would also prevent loading around the tip of the stem, which had potentially caused the pain.A new bearing was implanted and the knee closed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may 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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: UNIVERSAL STEM 115X14MM 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: 11813756
• Report Number: 1818910-2021-10122
• Device Sequence Number: 19830930
• Product Code: JWH
• UDI-Device Identifier: 10603295217909
• UDI-Public: 10603295217909
• 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 Implanted Year: 2018
• 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
• Report Date (Section B): 04/27/2021

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: 86-7428
• Device Catalogue Number: 867428
• Device Lot Number: HA6290
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 07/16/2021
• 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 SZ 4; MBT TRAY SLEEVE POR M/L 53MM; PFC*SIGMA TC3 FEM RT SZ4; PFC*SIGMA/OV/DOME PAT 3PEG,41; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; TC3 RP TIBIAL INSERT S4,10.0; UNIVERSAL FEM SLV FUL POR 34MM; UNIVERSAL STEM 115X14MM FLUTED; UNIVERSAL STEM 75X18MM FLUTED; UNK MANUFACTURER & PRODUCT INFO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR