MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP

Catalog Number UNK HIP ACETABULAR CUP

Device Problem Difficult to Insert (1316)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 06/29/2020

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

Insert was too small for cup.No fit when inserting.Where / when did the event occur? intra-op.Was surgery time extended as a direct result of incident? yes, with approximately 15 minutes.What action was taken/required to manage the problem during the procedure? with same like product.Was a patient involved? yes.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the acetabular cup associated with this report was not received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.H10 additional narrative: added: e1 (facility name).Corrected h6 patient code: no code available (3191) from the initial medwatch to capture patient harm surgery prolonged, insufficient information.

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10266326
• MDR Text Key: 199237335
• Report Number: 1818910-2020-15677
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PINN MAR NEUT 32IDX56OD.; UNKNOWN HIP ACETABULAR CUP.