MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER INSERT 32ID X 48OD; HIP CERAMIC ACETABULAR LINERS

Catalog Number 121882748

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 11/08/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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

This case is logged to capture previous revision mentioned in (b)(4).Previous revision was a change of femoral head from +5mm to +9mm 32mm ceramic head dislocation was the same reason for the previous revision.(b)(4): patient has been complaining of a "clunking" hip replacement after 2 years post-op.There has already been a revision change of head to the femoral stem to counteract the issue, but she still appears to be able to manually dislocate the hip with force.She has come back today for revision surgery again, this time to remove the cup and liner and replace with new components.Upon open the hip joint there were fragments of ceramic in the wound, this appeared to be from the ceramic liner as the head looks in pristine condition.Once cup was removed it appears there is a section of the ceramic liner that has fractured off, this is in line with the fragments found in the wound.The surgeon states that it is very hard to manually reproduce the dislocation the patient is experiencing.The head and liner both show signs of metal wear against components in keeping with the narrative of being able to dislocate at will.A new head, liner and cup were replaced as expected and i will follow-up in coming months to see if the same problem persists after this surgery.

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.

Event Description

Additional information was received indicating that it was a left-sided operation.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: this case is logged to capture previous revision mentioned in (b)(4).Previous revision was a change of femoral head from +5mm to +9mm 32mm ceramic head.Dislocation was the same reason for the previous revision.The product was not returned to depuy synthes.However, a photo was provided for review.The photograph attached was reviewed.However, it does not represents the reported revision.Therefore, the investigation could not draw any conclusions about the reported event, due to the insufficient evidence provided.As the device was not returned, an as-received condition could not be assessed.And a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed, as the photographs provided are not representative of the reported complaint condition.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 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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.The date of explant ((b)(6) 2022), in the initial medwatch is being retracted, since the liner was not revised.

• Brand Name: DELTA CER INSERT 32ID X 48OD
• Type of Device: HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18275939
• MDR Text Key: 329847727
• Report Number: 1818910-2023-24757
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 12/06/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121882748
• Device Lot Number: 9656514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 12/06/2023; 02/20/2024; 02/23/2024
• Supplement Dates FDA Received: 12/19/2023; 02/22/2024; 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2020
• 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 36MM +5; DLT TS CER HD 12/14 32MM +9; UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention
• Patient Sex: Female