MAUDE Adverse Event Report: DEPUY RAYNHAM 1219655 TAPER CEM STEM 15X90; KNEE OTHER IMPLANT

Catalog Number 866469

Device Problems Product Quality Problem (1506); Defective Device (2588); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 09/05/2017

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 stem was damaged along the threaded section.

Manufacturer Narrative

Examination of the returned device confirmed the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TAPER CEM STEM 15X90
• Type of Device: KNEE OTHER IMPLANT
• Manufacturer (Section D): DEPUY RAYNHAM 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY RAYNHAM 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6957525
• MDR Text Key: 89935836
• Report Number: 1818910-2017-26663
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295217183
• UDI-Public: 10603295217183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/18/2017

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: 866469
• Device Lot Number: EH6NM4000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2017
• Initial Date FDA Received: 10/18/2017
• Supplement Dates Manufacturer Received: 10/29/2017
• Supplement Dates FDA Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/16/2015
• 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