MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 HP ALIGNMENT TOWER; KNEE INSTRUMENT/TRIAL

Catalog Number 950501307

Device Problem Bent (1059)

Patient Problem No Information (3190)

Event Date 10/24/2017

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 one of the teeth to the alignment tower was bent.It was also reported that due to the bend it would not insert into the tibia cutting block.

Manufacturer Narrative

The device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event without the device to examine.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: HP ALIGNMENT TOWER
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 7048626
• MDR Text Key: 93052449
• Report Number: 1818910-2017-29529
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295226048
• UDI-Public: 10603295226048
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/24/2017

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: 950501307
• Device Lot Number: J1108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 11/21/2017
• Supplement Dates Manufacturer Received: 12/06/2017
• Supplement Dates FDA Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 63 YR