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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2022

Event Type  malfunction  

Event Description

Stryker rep reported the wrong size implant in box.

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 as the primary product and the information for the device that was actually inside the package is being listed.6570-0-032; delta v-40 ceramic head 32/-4.

Manufacturer Narrative

Reported event: an event regarding product mix involving a ceramic head was reported.The event was confirmed by review of the returned device.Method & results: product evaluation and results: the outer box of the device shows catalog number 6570-0-032, lot 89648802 on the label and also shows that the device was intended to be a 32mm head with a nk lnth of -4mm.The device packaged bears the marking 32mm +4.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 8 other similar events for the lot referenced.Conclusions: the reported product mix was confirmed.

Event Description

Stryker rep reported the wrong size implant in box.

• 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: 13502023
• MDR Text Key: 285625658
• Report Number: 0002249697-2022-00204
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 04546540608475
• UDI-Public: 04546540608475
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K052718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/14/2022
• Initial Date FDA Received: 02/09/2022
• Supplement Dates Manufacturer Received: 03/09/2022
• Supplement Dates FDA Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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