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

Catalog Number 217863136

Device Problems Dull, Blunt (2407); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: examination and function testing of the submitted device did not confirm 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.

Event Description

The instruments were reported for an unknown reason.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary; examination and function testing of the submitted device did not confirm the reported event.Examination and functional testing of the submitted adapter found the connection feature that attaches to the reamer is damaged.The damage is consistent with the reamers mating feature stripping after being subjected to hard cortical bone and heavy usage causing damage/wear to the connection feature of the adapter.The root cause is attributed to product wear out.

• Brand Name: MODIFIED HUDSON ADAPTER
• Type of Device: KNEE INSTRUMENT : ADAPTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 5743725905
• MDR Report Key: 7866581
• MDR Text Key: 119935051
• Report Number: 1818910-2018-69021
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 10603295096252
• UDI-Public: 10603295096252
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/16/2018

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: 217863136
• Device Lot Number: H0210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2018
• Initial Date FDA Received: 09/11/2018
• Supplement Dates Manufacturer Received: 08/16/2018
• Supplement Dates FDA Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/16/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 43 YR