MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TC3 RP TIBIAL INSERT S2.5,25.0; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT

Catalog Number 962337

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2019

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the inner portion of the package was damaged.Discovered upon opening.Doe: (b)(6) 2019.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: the packaging component associated with the reported event was not returned for evaluation.The investigation could not confirm the reported package damage or draw any conclusions about the root cause without the packaging to examine.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.No device or packaging components associated with the reported event were returned for evaluation.A worldwide complaint database search found no additional reports against the provided tc3 rp tibial insert s2.5,25.0 (product code: 962337, lot: 636350).A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing that would contribute to the reported event.The investigation could not verify or identify any product contribution to the reported event with the information provided as the reported device and/or packaging components were not returned for evaluation.Based on the inability to confirm the reported event or draw any conclusions about root cause, the need for corrective action was not indicated.Monitor complaints through post market surveillance sep-419.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.Update may 20, 2019: received complaint device and packaging materials.The complaint consisted of the product and outer package component for 962337 tc3 rp tibial insert s2.5,25.0, lot code 636350.Examination of the returned outer carton and hard blister cavity did not reveal any damage or manufacturing defects to the blister or blister seal.The complaint subject inner-most packaging (gvf) was not returned for examination.A worldwide complaint database search found no additional reports against the provided product code/lot code combination.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any additional reported events or nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.The investigation could not confirm the reported package damage or draw any conclusions about the root cause without the gvf packaging to examine.Based on the inability to identify product malfunction/error as a contributing factor to the reported package damage, the need for corrective action is not indicated.Complaint trends will be monitored by post market surveillance through sep-419.Depuy synthes considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.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. .

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.Additional narrative: product complaint # (b)(4).Investigation summary: no device or packaging components associated with the reported event were returned for evaluation.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.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.

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.Product complaint (b)(4).Investigation summary : the packaging component associated with the reported event was not returned for evaluation.The investigation could not confirm the reported package damage or draw any conclusions about the root cause without the packaging to examine.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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: TC3 RP TIBIAL INSERT S2.5,25.0
• Type of Device: SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8483653
• MDR Text Key: 140932404
• Report Number: 1818910-2019-89780
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295242185
• UDI-Public: 10603295242185
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/15/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 962337
• Device Lot Number: 636350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Initial Date Manufacturer Received: 03/15/2019
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 05/07/2019; 05/17/2019; 05/21/2019
• Supplement Dates FDA Received: 05/07/2019; 05/27/2019; 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR