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

Catalog Number	866469
Medical Device Problem Codes	Product Quality Problem (1506); Defective Device (2588); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 was reported that the stem was damaged along the threaded section.
Additional 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
• Common Device Name: KNEE OTHER IMPLANT
• Manufacturer (Section D): DEPUY RAYNHAM 1219655; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6957525
• Report Number: 1818910-2017-26663
• Device Sequence Number: 19117992
• Product Code: JWH
• UDI-Device Identifier: 10603295217183
• UDI-Public: 10603295217183
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K882234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 09/18/2017
• Supplement Date Received by Manufacturer: 10/29/2017
• Initial Report FDA Received Date: 10/18/2017
• Supplement Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1