MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA XLKCVDPLUS INS2.5 12.5MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	97-0442
Medical Device Problem Codes	Expiration Date Error (2528); Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2019
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It has come to notice today about surgery done on monday (b)(6) 2019.Expired articular surface implant in the knee construct size (2.5* 12.5) has been implanted in the patient knee.The implants for the surgery supplied by universal traders, pune.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: corrected:h6(device).Product complaint (b)(4).Investigation summary: the complaint was received into the company with the following comment: it has come to notice today about surgery done on monday (b)(6) 2019 at (b)(6) hospital (b)(6) hospital by dr.(b)(6).Expired articular surface implant in the knee construct size (2.5* 12.5) has been implanted in the patient knee.The implants for the surgery supplied by (b)(4).The impacted product is (1) sigma xlkcvdplus ins2.5 12.5mm, prod code 970442, lot no 554517.The complainant implanted the product (b)(6) 2019 and according to our records the expiry date for the product was 31 july 2019.The insert is a depuy product that is not known to degrade over time.When the sterile barriers are undamaged, it is reasonable to expect that sterility is maintained.As long as the sterile seals on the packaging remain intact the risk of loss of sterility 4 months past the expiration date is low.Therefore, standard practices of hospital staff to visually inspect all sterile packaging prior to opening and introducing the product to the sterile table will ensure that the risk of infection to the patient is low.Even though changes in the performance of the insert 4 months after the expiry date are considered to be low, the risks during any surgical procedure are varied and not within the control of the manufacturer.It is always advisable to monitor a patient for signs of postoperative infection and for postoperative stability of the implant.Please note that all depuy-synthes product should be used strictly within the expiration date on product labelling and doing otherwise is totally the responsibility of the medical staff.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.Root cause is attributed to intentional off label, unapproved, or contraindicated use.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIGMA XLKCVDPLUS INS2.5 12.5MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9401905
• Report Number: 1818910-2019-119581
• Device Sequence Number: 2090483
• Product Code: JWH
• UDI-Device Identifier: 10603295250500
• UDI-Public: 10603295250500
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2019

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 Expiration Date: 07/31/2019
• Device Model Number: 97-0442
• Device Catalogue Number: 970442
• Device Lot Number: 554517
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1