MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MODULAR CATHCART BALL 45MM OD; HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI

Model Number 1363-45-000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 03/06/2021

Event Type  Injury  

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

It was reported that an i&d was done due to a hematoma.No implants were removed.Doi: (b)(6) 2021; doe: (b)(6) 2021; unknown affected side.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received states that the affected side of the patient was the left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was 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.Device history lot : the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: MODULAR CATHCART BALL 45MM OD
• Type of Device: HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11574726
• MDR Text Key: 242427592
• Report Number: 1818910-2021-06221
• Device Sequence Number: 1
• Product Code: LZY
• UDI-Device Identifier: 10603295032779
• UDI-Public: 10603295032779
• Combination Product (y/n): N
• PMA/PMN Number: K903084
• 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: 03/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1363-45-000
• Device Catalogue Number: 136345000
• Device Lot Number: D201000416
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODULAR CATHCART BALL 45MM OD; SUMMIT POR TAPER SZ6 STD OFF; TAPERED SPACER ARTICUL/EZE +0; MODULAR CATHCART BALL 45MM OD; SUMMIT POR TAPER SZ6 STD OFF; TAPERED SPACER ARTICUL/EZE +0
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR