MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FEM RT SZ 5; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	96-0015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Fall (1848); Pain (1994); No Code Available (3191)
Date of Event	06/23/2020
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
Clinical adverse event received for wound dehiscence of incision; fall resulting in opening of his surgical incision.Event is serious and is considered moderate.Event is definitely not related to device and is possibly related to procedure.Date of implantation: (b)(6) 2020.Date of event (onset): (b)(6) 2020; (left knee).Treatment: surgical intervention with irrigation and debridement.
Additional Manufacturer Narrative
Product complaint # (b)(4).No device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Patient code: no code available (3191) was used to capture surgical intervention.Removed the code device revision or replacement.Retracting the reported product return in d10 and in h3, since only photos were received.
Event or Problem Description
Additional information received for medical records.Patient received bilateral depuy hybrid tkas to treat chronic pain secondary to end-stage arthrosis.This complaint will capture the left knee.The patella was resurfaced and depuy cement x 2 was utilized.The surgeon notes the left knee had 1-mm laxity in varus/valgus stresses in flexion and extension.The procedure was completed without complications.Patient received a surgical i & d and wound repair to treat pain and wound dehiscence secondary to a fall.There was no reported product problem with any implant and there were no revisions performed.The procedure was completed without complications.*of note* the patient sustained an impacted trochanteric fracture during the fall.In consultation with an sme, it was determined to note the trochanteric fracture as a note on this complaint.There was no information regarding treatment of the fracture.Therefore, it will not be captured within this complaint.Doi: (b)(6) 2020, doe: (b)(6) 2020, left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5, b7, h6 patient code.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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 incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.H10 additional narrative:  added: d10.Corrected: h3.

• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10262401
• Report Number: 1818910-2020-15599
• Device Sequence Number: 19415736
• Product Code: JWH
• UDI-Device Identifier: 10603295232049
• UDI-Public: 10603295232049
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K943462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/02/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 96-0015
• Device Catalogue Number: 960015
• Device Lot Number: 9159329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 07/17/2020; 08/17/2020; 08/21/2020
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 07/27/2020; 08/19/2020; 08/24/2020
• 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: DEPUY CMW 1 40G.; DEPUY CMW 1 40G.; MBT CEM KEEL TIB TRAY SZ5.; PFC*SIGMA C/R NPOR FEM RT SZ 5.; PFC*SIGMA/OV/DOME PAT 3PEG,41.; SIG RP AOX CRV INS SZ5 12.5.; DEPUY CMW 1 40G; DEPUY CMW 1 40G; MBT CEM KEEL TIB TRAY SZ5; PFC*SIGMA C/R NPOR FEM RT SZ 5; PFC*SIGMA/OV/DOME PAT 3PEG,41; SIG RP AOX CRV INS SZ5 12.5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 78