MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MODIFIED HUDSON ADAPTER; KNEE INSTRUMENT : ADAPTORS

Catalog Number 217863136

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Instrument is worn and needs to be replaced.Nothing fell into patient.No patient consequence and no surgical delay.One each impacted, one each needing replacement.No charge replacement po to follow.(b)(4).Patient consequence?: no.Is the information being submitted for this complaint all the details that are known/available regarding this event?: yes.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: examination of the submitted confirmed the reported damage.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: MODIFIED HUDSON ADAPTER
• Type of Device: KNEE INSTRUMENT : ADAPTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7269631
• MDR Text Key: 100249676
• Report Number: 1818910-2018-53406
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295096252
• UDI-Public: 10603295096252
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 217863136
• Device Lot Number: H0707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2007
• 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