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
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a surgeon noticed the actual implanted head was not -4mm, it was +4mm head.
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.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.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.Product field action has been initiated.Investigation ongoing.
Additional Manufacturer Narrative
Reported event: an event regarding product mix involving a ceramic head was reported.The event is in the scope of nc and therefore the event is confirmed.Method & results: product evaluation and results: not performed as the device remained implanted.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.Nc was raised to further address this event.
Event or Problem Description
It was reported that a surgeon noticed the actual implanted head was not -4mm, it was +4mm head.

• Brand Name: DELTA V-40 CERAMIC HEAD 32/-4
• Common Device Name: 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14672585
• Report Number: 0002249697-2022-00818
• Device Sequence Number: 4855482
• Product Code: LZO
• UDI-Device Identifier: 04546540608475
• UDI-Public: 04546540608475
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K052718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2022

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: 6570-0-032
• Device Catalogue Number: 6570-0-032
• Device Lot Number: 89648802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 06/12/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• 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