MAUDE Adverse Event Report: DEPUY RAYNHAM ¿ 1219655 UNIVERSAL STEM 115X12MM FLUTED; KNEE OTHER IMPLANT

Catalog Number	867426
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/20/2017
Type of Reportable Event	Serious Injury
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
Patient was revised to address loosening of femoral implant at the cement/bone interface and tibial component loosening at the at bone to cement interface.Depuy cement was used.It was also stated that the femoral stem was not tight on the femoral adapter.
Additional Manufacturer Narrative
Additional narrative: the device associated with this report was not returned for examination.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: UNIVERSAL STEM 115X12MM FLUTED
• Common Device Name: KNEE OTHER IMPLANT
• Manufacturer (Section D): DEPUY RAYNHAM ¿ 1219655; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6718790
• Report Number: 1818910-2017-21231
• Device Sequence Number: 999490
• Product Code: JWH
• UDI-Device Identifier: 10603295217893
• UDI-Public: 10603295217893
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K063633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 867426
• Device Lot Number: 666179
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2017
• Supplement Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 07/17/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention