MAUDE Adverse Event Report: DEPUY CMW 9610921 SS CEMENT RESTRICTOR TRIAL 3; CEMENT / CEMENT ACCESSORY

Catalog Number	546034000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/19/2017
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
It was reported that the surgeon mistakenly implanted a trial instrument ¿ c stem cement restrictor trial.
Additional Manufacturer Narrative
It was reported that the surgeon mistakenly implanted a trial instrument ¿ c stem cement restrictor trial.The reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.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: SS CEMENT RESTRICTOR TRIAL 3
• Common Device Name: CEMENT / CEMENT ACCESSORY
• Manufacturer (Section D): DEPUY CMW 9610921; cornford rd; blackpool IN FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 6960821
• Report Number: 1818910-2017-26753
• Device Sequence Number: 18974264
• Product Code: LXH
• UDI-Device Identifier: 10603295174417
• UDI-Public: 10603295174417
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 09/19/2017

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: 546034000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2017
• Supplement Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 10/19/2017
• Supplement Report FDA Received Date: 11/16/2017
• 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: Other