MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA MODULAR SLEEVE 12/14 M; DELTAMOTION : HIP FEMORAL AUGMENT

Catalog Number 167061F

Device Problem Noise, Audible (3273)

Patient Problem Joint Laxity (4526)

Event Date 11/12/2020

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

Delta motion cup and head exchange to treat noise and joint instability secondary to impingement.Surgeon implanted a competitor cup and ceramic ts head.

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.H10 additional narrative: added: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

We would like to confirm if the liner was also revised, if yes, kindly provide the part and lot of liner and cup.Response: delta motion cup, is inclusive of the liner, it is a one-piece system, there is no separate product code.

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 : a worldwide complaint search was performed for complaints received since 01 jan 2015, due to the limitations of the complaint database search tool.No additional previous reports against the provided product code/lot code combination were found.However, since the current product/lot combination was manufactured prior to 01 jan 2015 the results of the search are inconclusive.Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: DELTA MODULAR SLEEVE 12/14 M
• Type of Device: DELTAMOTION : HIP FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10934666
• MDR Text Key: 219154730
• Report Number: 1818910-2020-25939
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 167061F
• Device Lot Number: 121591
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELTA MODULAR HEAD 48MM; DELTA MODULAR SLEEVE 12/14 M; DELTA MODULAR HEAD 48MM; DELTA MODULAR SLEEVE 12/14 M
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR