MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR POLY/METAL HEMI

Catalog Number UNK HIP ACETABULAR POLY/METAL

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

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 06/29/2022

Event Type  Injury  

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

This (b)(4) is related to (b)(4) which reports that infection occurred after the primary surgery.This pc reports that heart failure occurred after the revision surgery.It was reported that on (b)(6) 2022, debridement and removal of the bipolar were performed due to infection.After that, the surgeon was following up the patient while using antimicrobials.However, heart failure occurred.Therefore, the surgeon decided to remove the stem and insert a spacer mold to calm the infection.No further information is available.

Event Description

Additional information received indicated that the physician confirmed that there was no casual relationship between heart failure and the product in question.

Manufacturer Narrative

Product complaint # (b)(4).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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre) was not possible because the required lot code was not provided.

• Brand Name: UNKNOWN HIP ACETABULAR POLY/METAL HEMI
• Type of Device: HIP ACETABULAR POLY/METAL HEMI
• 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 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15026636
• MDR Text Key: 295956555
• Report Number: 1818910-2022-13064
• Device Sequence Number: 1
• Product Code: LZY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR POLY/METAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/15/2022
• Supplement Dates Manufacturer Received: 07/20/2022; 07/29/2022
• Supplement Dates FDA Received: 07/21/2022; 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACTIS COLLARED STD SIZE 6; UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention