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	02/26/2021
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 pain and instability.No surgical delay reported doi: (b)(6) 2017, 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.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 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: 11455600
• Report Number: 1818910-2021-04855
• Device Sequence Number: 17022553
• Product Code: JWH
• UDI-Device Identifier: 10603295217862
• UDI-Public: 10603295217862
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 02/26/2021

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: H57505
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 04/15/2021
• 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: BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN); MBT REVISION CEM TIB TRAY SZ 4; MBT TRAY SLEEVE POR M/L 61MM; PFC SIGMA FEM POST AUG SZ5 4MM; PFC*SIGMA DIS AUG 4MM,SZ5,LEFT; PFC*SIGMA DIS AUG 8MM,SZ5,LEFT; PFC*SIGMA TC3 FEM LEFT SZ5; TC3 RP TIBIAL INSERT S5,20.0; UNIVERSAL STEM 75X18MM FLUTED; UNIVERSAL STEM 75X22MM FLUTED; BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN); MBT REVISION CEM TIB TRAY SZ 4; MBT TRAY SLEEVE POR M/L 61MM; PFC SIGMA FEM POST AUG SZ5 4MM; PFC*SIGMA DIS AUG 4MM,SZ5,LEFT; PFC*SIGMA DIS AUG 8MM,SZ5,LEFT; PFC*SIGMA TC3 FEM LEFT SZ5; TC3 RP TIBIAL INSERT S5,20.0; UNIVERSAL STEM 75X18MM FLUTED; UNIVERSAL STEM 75X22MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR