MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 32/-4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number 6570-0-032

Device Problem Inaccurate Information (4051)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2021

Event Type  malfunction  

Event Description

It was reported that our customer checked x-ray for pfa ((b)(4) , the surgeon suspected it was +4mm/32mm.

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There has been 3 similar events for the lot referenced.This is a product mix issue, so the device information located on the outer box label is being reported the information for the device that was actually inside the package is : cat# 6570-0-232; delta v-40, ceramic head 32/+4; lot# unknown.Product field action has been initiated.Investigation ongoing.Device not returned to the manufacturer.

Manufacturer Narrative

Reported event: an event regarding product mix involving a ceramic head was reported.The event was confirmed by review of the photographs provided.Method & results: product evaluation and results: visual, dimensional, functional and material analysis 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 other similar events for the lot referenced.Conclusions: the reported product mix was confirmed.Nc was raised to further address this event.This is a product mix issue, so the device information located on the outer box label is being reported in section d and the information for the device that was actually inside the package is: cat# 6570-0-232; delta v-40 ceramic head 32/+4; lot# 89546202.

Event Description

It was reported that our customer checked x-ray for pfa (pr2911632), the surgeon suspected it was +4mm/32mm.

• Brand Name: DELTA V-40 CERAMIC HEAD 32/-4
• 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: 13664366
• MDR Text Key: 287012016
• Report Number: 0002249697-2022-00314
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 04546540608475
• UDI-Public: 04546540608475
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K052718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6570-0-032
• Device Catalogue Number: 6570-0-032
• Device Lot Number: 89648802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2022
• Initial Date FDA Received: 03/03/2022
• Supplement Dates Manufacturer Received: 04/27/2022
• Supplement Dates FDA Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: PFA 2902313
• Patient Sequence Number: 1
• Patient Outcome(s): Other