MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNIVERSAL STEM 75X10MM FLUTED; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Catalog Number	867410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); No Code Available (3191)
Date of Event	08/26/2011
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.Concomitant med products: mbt revision cem tib tray sz 2; srom nrh fem w/pin xsmrt 66x58; lps univ tib hin ins xsm 12mm; unknown knee patella component; depuy cmw 2 20g; universal fem slv ful por 31mm; universal stem 75x14mm fluted; srom nrh dist aug xs/s/md 5mm; srom nrh dist aug xs/s/md 10mm; universal stem 75x10mm fluted; mbt tray sleeve por m/l 29mm.
Event or Problem Description
Subject:(b)(6).Clinical adverse event received for above the knee amputation related to wound dehiscence.Event is serious and is considered severe.Event is possibly related to device and definitely related to procedure.Doe: (b)(6) 2011/ doi: (b)(6) 2011 / date of amputation: (b)(6) 2011.(right, knee).
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incident(s) against the provided product/lot combination(s) since release for distribution.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNIVERSAL STEM 75X10MM FLUTED
• Common Device Name: UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7781141
• Report Number: 1818910-2018-66583
• Device Sequence Number: 1392194
• Product Code: JWH
• UDI-Device Identifier: 10603295217800
• UDI-Public: 10603295217800
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2018

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 Catalogue Number: 867410
• Device Lot Number: CB2DY4000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 78