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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/04/2020
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
It was reported that during a knee revision, the surgeon impacted the tibial stem/sleeve/tray construct.There was dense sclerotic bone in the canal.This caused the spline of the stem to bend and deform.He decided to bring the patient back and revised to a shorter cemented construct.Doi: (b)(6) 2020; dor: (b)(6) 2020; left knee.
Event or Problem Description
Update additional information received 21 feb 2020.It was reported that the reason for revision was due to the tibial tray that the spline on the component bent on.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• 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: 9711421
• Report Number: 1818910-2020-04866
• Device Sequence Number: 2513802
• Product Code: JWH
• UDI-Device Identifier: 10603295217909
• UDI-Public: 10603295217909
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K063633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2020

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: 86-7428
• Device Catalogue Number: 867428
• Device Lot Number: J0177X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 02/21/2020; 07/20/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 03/13/2020; 07/22/2020
• 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: COMPETITOR CEMENT; MBT REVISION CEM TIB TRAY SZ 4; MBT TRAY SLEEVE POR M/L 45MM; TC3 RP TIBIAL INSERT S4,20.0
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR