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

Model Number	6570-0-232
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Additional 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: the outer box of the device shows catalog number 6570-0-232, lot 89546202 on the label and also shows that the device was intended to be a 32mm head with a nk lnth of +4mm.A photo showing that 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.An nc was raised to further address this event.Product surveillance will continue to monitor for trends.Corrective action/preventive action: 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 and the information for the device that was actually inside the package is: 6570-0-032 delta v-40 ceramic head 32/-4 lot 89648802 product field action has been initiated.
Event or Problem Description
Primary procedure, left hip.It was reported that an implant's packaging and labels indicated a 32 +4 ceramic head, but the device was marked as a 32 -4 ceramic head.A second device of the same lot was opened and the same issue occurred.A 32 +4 head of a different lot was opened and implanted.Procedure completed successfully with a delay of approximately 2 minutes.Rep confirmed the implants were hospital owned.Rep confirmed that he can provide pictures, and that no further information will be released by the hospital or surgeon.

• Brand Name: DELTA V-40 CERAMIC HEAD 32/+4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 13939618
• Report Number: 0002249697-2022-00454
• Device Sequence Number: 11881190
• Product Code: JDI
• UDI-Device Identifier: 04546540608536
• UDI-Public: 04546540608536
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/29/2022

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
• Operator of Device: Health Professional
• Device Model Number: 6570-0-232
• Device Catalogue Number: 6570-0-232
• Device Lot Number: 89546202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: PFA 2902313
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown