MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFCSIG FLUT FEMROD 5DG16X125MM; SIGMA REVISION IMPLANT : KNEE STEMS

Catalog Number	960702
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/15/2018
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 4 knee tibial tray component; pfc*sigma tc3 fem rt sz5 knee femur component; tc3 rp tibial insert s5,10.0 knee tibial insert component; pfc*sigma/ov/dome pat 3peg,38 knee patella component; unknown bone cement; mbt tray sleeve por m/l 45mm knee metaphyseal sleeve component; pfc sigma fem stem bolt knee femur stem component; pfc sig flut fem rod 5dg16x125mm knee femur stem component; p.F.C.* flut tib rod 115x16mm knee tibia stem component; pfc sigma fem post aug sz5 8mm knee femur augment component; pfc sigma fem post aug sz5 8mm knee femur augment component.
Event or Problem Description
The primary surgery performed on (b)(6) 2018.It was reported that the surgeon recognized that infection on the patient¿s knee on (b)(6) 2018.Since the surgeon could not control the infection, implants were explanted from the patient's knee joint due to postoperative infection, and cement spacer was placed in the patient's knee joint for treatment the knee joint infection on (b)(6) 2018.There was no surgical delay.No further information was provided by the hospital.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.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.Device history lot: product code: 960702, lot number: d15122267.Device history review: review of the device history records did not reveal any related manufacturing deviations or anomalies.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFCSIG FLUT FEMROD 5DG16X125MM
• Common Device Name: SIGMA REVISION IMPLANT : KNEE STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7868752
• Report Number: 1818910-2018-69125
• Device Sequence Number: 1835715
• Product Code: JWH
• UDI-Device Identifier: 10603295233633
• UDI-Public: 10603295233633
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2018

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: 960702
• Device Lot Number: D15122267
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 11/13/2018
• 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