MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC 1818910 SIGMA PS CEM FEM SZ2 L; SIGMA KNEE PRIMARY : KNEE FEMORAL

Catalog Number	196040200
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2018
Type of Reportable Event	Malfunction
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
It was reported that the cement was overflowed out of the hole of the reported implant when the surgeon inserted the implant during tka surgery on (b)(6) 2018.The surgeon found that there was no polyethylene part to cover the hole of the implant.The surgery was completed by scrapping off of the overflowing cement, but the cement was remained around the hole.After surgery, the surgeon searched for the container in which the implant was in, but could not find the polyethylene parts.There was no surgical delay and there was no adverse consequence to the patient.No further information was provided by the hospital.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot, product code: (b)(4), lot number (b)(4).Device history review: (b)(4) review.Product code (b)(4), work order (b)(4), was manufactured on (b)(4) 2017.12 parts were manufactured per specification and all raw materials met specification.

• Brand Name: SIGMA PS CEM FEM SZ2 L
• 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: 7479096
• Report Number: 1818910-2018-58694
• Device Sequence Number: 10846126
• Product Code: JWH
• UDI-Device Identifier: 10603295075028
• UDI-Public: 10603295075028
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K073529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 196040200
• Device Lot Number: 8549055
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1