MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	0580-1-442
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.Complaint history review: there have been 13 other similar events for the reported lot all related to the same issue.This event is deemed to be a manufacturing issue.Manufacturing nc was issued on 15 aug 2025 for this event.This mdr is for the catalog and lot number on the box and label (0580-1-442, lot a00976), which did not correspond to the catalog and lot number laser marked on the stem (0580-1-352, lot g8754849).
Event or Problem Description
This report is for the stem implanted on (b)(6) 2025.When i was following up on product field action responses, a customer copied me into an email chain and noted that a stem was already implanted into patient.Surgeon was satisfied with the outcomes of the procedure and has not reported any issues related to the size of the implant.No negative impacts noted by the patient.Date of implant was (b)(6) 2025: the pfa and communications to customers were sent on (b)(6) 2025.From the customer (lead theatre practitioner): "the exeter v40 stem was implanted on (b)(6) 2025.I have confirmed with surgeon that they are satisfied with the outcomes of the procedure.Furthermore, they have not reported any issues related to the size of the implant, nor have there been any negative impacts noted by the patient at this time.".

• Brand Name: EXETER V40 STEM 44MM NO 2
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24508528
• Report Number: 0002249697-2026-00173
• Device Sequence Number: 9960355
• Product Code: LPH
• UDI-Device Identifier: 04546540153319
• UDI-Public: 04546540153319
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

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 Catalogue Number: 0580-1-442
• Device Lot Number: A00976
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• 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 4085828
• Patient Sequence Number: 1
• Patient Sex: Unknown