MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC*SIGMA C/R NPOR FEM LT SZ 4; SIGMA KNEE PRIMARY : KNEE FEMORAL

Catalog Number 960004

Device Problem Delivered as Unsterile Product (1421)

Patient Problem Not Applicable (3189)

Event Date 10/30/2018

Event Type  malfunction  

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.

Event Description

During a routine pfc tkr, on handling the implant before implantation, it was noticed a glue, sticky area, by the implant.He then noticed a water marks on the femoral condyles.A new implant was opened and implanted.The affected implant was discarded.It will be returned as no bodily fluids have been in contact with the implant.The surgery was delayed by 5 mins.

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.

Manufacturer Narrative

(b)(4).Investigation summary: the device was received and confirmed the presence of foam on the device.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : 12 parts were manufactured per specification and all raw materials met specification.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.

• Type of Device: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu 21512 6; CH 215126
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 8096272
• MDR Text Key: 128103290
• Report Number: 1818910-2018-76203
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295231967
• UDI-Public: 10603295231967
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K943462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 960004
• Device Lot Number: D18071185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1