MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 36/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 6570-0-136

Device Problem Insufficient Information (3190)

Patient Problem Unequal Limb Length (4534)

Event Date 06/01/2022

Event Type  Injury  

Event Description

Incident report received by the tga 15/09/2023.I'm concerned as this product was alerted by stryker in jan 2022 as a voluntary recall.I'm wondering if australia was issued the same alert? there are numerous documents that i have found online by stryker stating the product of this lot number was possibly defective and wrong sizing compared to what stated on product packaging.There were numerous complications mentioned in the alerts that it cause leg length discrepancy, weakness of the abductor muscle, hip dislocation of femoral head from acetabular cup, and pain and inability to walk leading to revision surgery.My partner had this device put in him last year on (b)(6) 2022 and had all these issues plus more.The pain and suffering has been over 15 months and very poor management post care from the surgeon which is really poor duty of care.

Manufacturer Narrative

Reported event: an event regarding limb length discrepancy involving a ceramic head was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.The patient would like to know if the implant was subject to a recall.Upon review, there are no recalls associated with this device.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text: device not returned to the manufacturer.

• Brand Name: DELTA V-40 CERAMIC HEAD 36/0
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18234583
• MDR Text Key: 329314893
• Report Number: 0002249697-2023-01470
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 04546540608512
• UDI-Public: 04546540608512
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K052718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2023

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: 6570-0-136
• Device Lot Number: 93950103
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2022
• 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 Outcome(s): Other
• Patient Sex: Male