MAUDE Adverse Event Report: DEPUY RAYHNAM ¿ 1219655 PFC SIGMARP CV TB/IN S4 15.0; KNEE TIBIAL BEARING/INSERT

Catalog Number 962043

Device Problem Delamination (2904)

Patient Problem No Information (3190)

Event Date 04/12/2016

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(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

The patient was revised to address spinout and delamination.

Manufacturer Narrative

No device associated with this report was received for examination.A complaint database search on the provided pfc sigmarp cv tb/in s4 15.0 (product code 962043, lot number 64960a) found an additional report and a dhr review was conducted.Review of the device history records did not reveal any related manufacturing deviations or anomalies on the provided product and lot combination.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.Depuy 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.

• Brand Name: PFC SIGMARP CV TB/IN S4 15.0
• Type of Device: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY RAYHNAM ¿ 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY RAYHNAM ¿ 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5575888
• MDR Text Key: 42604400
• Report Number: 1818910-2016-17326
• Device Sequence Number: 1
• Product Code: NJL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2006
• Device Catalogue Number: 962043
• Device Lot Number: 64960A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2001
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 109