MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG CERAMIC CERAMIC BALL HEAD DELTA 28 M; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 75007452

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Joint Dislocation (2374)

Event Date 10/13/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a total hip revision surgery had been conducted on (b)(6) 2023 to exchange the stem and head, the patient experienced two dislocations.This incident was addressed via revision surgery on (b)(6) 2023 by exchanging the ceramic ball head delta 28 m for a merete plug-in system.The patient current health status is unknown.

Event Description

It was reported that, after a total hip revision surgery had been conducted on (b)(6) 2023 to exchange the stem and head, the patient experienced two dislocations.This incident was addressed via revision surgery on (b)(6) 2023 by exchanging the ceramic ball head delta 28 m for a merete plug-in system.The sn stem and cup and the non-sn liner were retained.The patient current health status is unknown.

Manufacturer Narrative

Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: it was reported that, after a total hip revision surgery had been conducted on (b)(6) 2023 to exchange the stem and head, the patient experienced two dislocations.This incident was addressed via revision surgery on (b)(6) 2023 by exchanging the ceramic ball head delta 28 m for a merete plug-in system.The stem, cup and liner were retained.The device intended for use in treatment was not returned for investigation.A product evaluation was not possible.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.There is no evidence that the reported devices failed to meet manufacturing specifications upon release for distribution.The complaint history review for the complaint device revealed no additional complaints for the affected batch nor additional complaints for the same product number over the past 12 months with similar failure mode.A review of past corrective actions was performed.No further escalation is required.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.The instructions for use (lit.No.12.23, ed.03/21) states "joint dislocation" as a ¿potential adverse device effect¿ in combination with the implantation of a hip prosthesis.Based on the limited information provided, the clinical root cause of the reported dislocations could not be confirmed.However, the use of cemented non-s+n insert, the recent change of the hip stem and recent hip revision are likely contributory factors.The patient impact includes the dislocations and subsequent revision surgery and associated recovery period.It is unknown the future impact of having the mixed components of different manufacturers.The performed investigation does not lead to an accurately determined cause.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight and trauma to the joint replacement.There is no need for further actions.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.Corrected data: b5 (narrative updated).

• Brand Name: CERAMIC CERAMIC BALL HEAD DELTA 28 M
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18338600
• MDR Text Key: 330666080
• Report Number: 9613369-2023-00226
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07611996085112
• UDI-Public: 7611996085112
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

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 Catalogue Number: 75007452
• Device Lot Number: B2204720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/15/2023
• Supplement Dates Manufacturer Received: 01/08/2024
• Supplement Dates FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2023
• 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
• Patient Age: 54 YR
• Patient Sex: Female