MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER INSERT 32ID X 50OD; HIP CERAMIC ACETABULAR LINERS

Catalog Number 121882750

Device Problem Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994)

Event Date 02/14/2024

Event Type  Injury  

Manufacturer Narrative

Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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

Hip revision due to unknown pain.The ceramic insert and the ceramic has been changed due to strange ceramic bearing.The head has a black mark on the side.The soft tissue seems to have some kind of metallosis.Doi: (b)(6) 2015 doe: (b)(6) 2024 reason for revision surgery.--> problem with the ceramic bearing, pain.

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).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: it was reported that hip revision due to unknown pain.The ceramic insert and the ceramic has been changed due to strange ceramic bearing.The head a black mark on the side.The soft tissue seems to have some kind of metallosis.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of the returned sample revealed that the delta cer insert 32id x 50od has blacks streaks inside the liner, and the ceramic head shows lines on the outer center.It can be concluded that a foreign fragment may have caused this damage.Therefore, it is reasonable to conclude that audible sound would be present due to the unintended articulation of the head and the liner.According to ifu-78992788, 103344855, rev.1, before seating the product, foreign bodies must be removed from the interface between the ceramic liner and the acetabular cup and the head, so that they are assembled properly.A dimensional inspection was not performed as it is not applicable to the complaint condition.A functional test was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the delta cer insert 32id x 50od would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: product code 121882750 work order 7954943 delta cer insert 32id x 500 d was manufactured on 26-jul-2014.(b)(4) parts were manufactured per specification and all raw materials met specification.There was no non-conformance associated with this lot.

• Brand Name: DELTA CER INSERT 32ID X 50OD
• Type of Device: HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18763711
• MDR Text Key: 336053364
• Report Number: 1818910-2024-04090
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/22/2024

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 Expiration Date: 06/30/2019
• Device Catalogue Number: 121882750
• Device Lot Number: 7954943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 03/27/2024; 04/22/2024; 05/14/2024
• Supplement Dates FDA Received: 04/01/2024; 04/23/2024; 05/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2014
• 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: DELTA CER HEAD 12/14 32MM +5; PINN SECTOR W/GRIPTION 50MM
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male