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

Model Number 2178-63-136

Device Problem Naturally Worn (2988)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 06/20/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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

It was reported where the reamer attaches to the hudson adapter, the hole was rounded out due to wear, making it hard for reamer to stay attached.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary : examination of the returned device confirmed the reported damage.The investigation findings with this individual complaint did not indicate that a broader investigation or corrective action was necessary.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Additional information received that the surgery time was extended.Minimal, t handle was used to remove the reamer so just a couple of seconds, 2.5 seconds.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5 and h6 (patient codes).H6 patient code: no code available (3191) used to capture the surgery prolonged and insufficient information.If information is obtained that was not available for the initial report, a follow-up report 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 46581 0988
• MDR Report Key: 10220985
• MDR Text Key: 198340501
• Report Number: 1818910-2020-14852
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 10603295096252
• UDI-Public: 10603295096252
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2020

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 Model Number: 2178-63-136
• Device Catalogue Number: 217863136
• Device Lot Number: TBXMV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Initial Date Manufacturer Received: 06/20/2020
• Initial Date FDA Received: 07/01/2020
• Supplement Dates Manufacturer Received: 06/20/2020; 08/13/2020
• Supplement Dates FDA Received: 07/07/2020; 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1