MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 36/+7,5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number 6570-0-736

Device Problem Corroded (1131)

Patient Problems Memory Loss/Impairment (1958); Pain (1994); Metal Related Pathology (4530)

Event Date 06/06/2019

Event Type  Injury  

Event Description

Rep reported the patient's left hip implanted on (b)(6) 2011 was revised on (b)(6) 2023.Initial patient complaints were pain, elevated ion levels, and memory loss.Intra-operatively, corrosion was noted at the stem/ neck interface and at the interface of the trunnion and ceramic head.The stem construct, head, and liner were revised.

Manufacturer Narrative

Reported event: an event regarding corrosion 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 event could not be confirmed as insufficient information was provided.Further information such as device return, pre- and post-operative x-rays, primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: DELTA V-40 CERAMIC HEAD 36/+7,5
• 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: 16697182
• MDR Text Key: 312860566
• Report Number: 0002249697-2023-00364
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 04546540608581
• UDI-Public: 04546540608581
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6570-0-736
• Device Catalogue Number: 6570-0-736
• Device Lot Number: 35423602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2020
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 91 KG