MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIG PS CEM FEM W/LUGS LT SZ5; SIGMA KNEE PRIMARY : KNEE FEMORAL

Catalog Number	196065500
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Not Applicable (3189)
Date of Event	04/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Der states that the patient presented with anterior pain and mid-flexion instability.Removed tibial insert, femoral and tibial components.Both femoral and tibial components appeared solidly fixed upon gross examination, and required extensive use of osteotomes and mini-saws to loosen for removal.Although the tibial tray showed little cement attachment on the underside upon removal (pictures attached), i cannot tell if that was a result of the use of the osteotomes and saws.The femoral component exhibited signs of cement attachment, although exposure did not allow full exploration of the underside of the femoral implant.Re-implanted size 5 tc-3 femoral with 2 each 4 mm posterior augments, and short cemented stem, mbt with 30 mm cemented stem and 53 mm metaphyseal sleeve, and a 15 mm tc-3 insert.Doi: (b)(6) 2017; dor: (b)(6) 2018; left knee.
Additional Manufacturer Narrative
Product complaint # :(b)(4).Investigation summary: no device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIG PS CEM FEM W/LUGS LT SZ5
• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7548773
• Report Number: 1818910-2018-60689
• Device Sequence Number: 18900845
• Product Code: JWH
• UDI-Device Identifier: 10603295075318
• UDI-Public: 10603295075318
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K073529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2018

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: 196065500
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/30/2018
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 07/03/2018
• 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 Age: 64 YR
• Patient Weight: 49